Rulemaking History for OTC External Analgesic Drug Products

Final Monograph (21 CFR part 348):
External Analgesic Drug Products for Over-the-Counter Human Use 

OTC External Analgesic Drug Products found on this page:

• Original Active Ingredients and Labeling
• Corticosteroids
• Diaper Rash
• Diphenhydramine
• Fever Blister and Cold Sore
• Aloe Vera and Urea
• Vaginal Douche Products
• Male Genital Desensitizers
• Patches, Plasters and Poultices
• Poison Ivy, Oak, Sumac and Insect Bites
• Insect Repellent
• Nonmonograph Ingredients

External Analgesic Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	12/4/1979	44FR69768
Correction	2/5/1980	45FR7820
Correction	3/25/1980	45FR19265
Reopening of Administrative Record: Panel recommends <2.5%>	9/26/1980	45FR63878
Extension of Comment Period	12/28/1982	47FR57738
Proposed Rule	Date	FR Citation
Tentative Final Monograph	2/8/1983	48FR5852
Correction	3/11/1983	48FR10373

External Analgesic Drug Products: Corticosteroids

Proposed Rule	Date	FR Citation
Tentative Final Monograph	2/8/1983	48FR5852
Proposed Rule: Adds seborrheic dermatitis/psoriasis indication for hydrocortisone	7/30/1986	51FR27360
Proposed Rule: Adds anal and genital itch indication for hydrocortisone	8/25/1988	53FR32592
Proposed Rule: Increases hydrocortisone concentration from 0.25% to 1%	2/27/1990	55FR6932
Notice of Enforcement: Allows marketing of 1% hydrocortisone	8/30/1991	56FR43025
Notice: Advisory Committee meeting on topical corticosteroid safety	2/17/2005	70FR8104

External Analgesic Drug Products: Diaper Rash

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	9/7/1982	47FR39412
Correction	12/7/1982	47FR54982
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies diaper rash indication as nonmonograph	6/20/1990	55FR25234
Final Rule	Date	FR Citation
Final Rule	12/18/1992	57FR60426

External Analgesic Drug Products: Diphenhydramine

Proposed Rule	Date	FR Citation
Proposed Rule: Adds warnings and directions	8/29/1997	62FR45767

External Analgesic Drug Products: Fever Blister and Cold Sore

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice Of Proposed Rulemaking	9/7/1982	47FR39412
Correction	12/7/1982	47FR54982
Proposed Rule	Date	FR Citation
Proposed Rule: Adds fever blister and cold sore indication	1/31/1990	55FR3370
Correction	3/27/1990	55FR11291

External Analgesic Drug Products: Aloe Vera and Urea

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data	12/31/2003	68FR75585

External Analgesic Drug Products: Vaginal Douche

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	11/19/1997	62FR61710

External Analgesic Drug Products: Male Genital Desensitizers

Proposed Rule	Date	FR Citation
Proposed Rule: Adds indication for benzocaine and lidocaine	10/2/1985	50FR40260
Final Rule	Date	FR Citation
Final Rule	6/19/1992	57FR27654

External Analgesic Drug Products: Patches, Plasters, and Poultices

Proposed Rule	Date	FR Citation
Proposed Rule: Classifies dosage forms as category III	7/17/2003	68FR42324

External Analgesic Drug Products: Poison Ivy, Oak, Sumac and Insect Bites

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Reopening of Administrative Record	9/7/1982	47FR39412
Correction	12/7/1982	47FR54982
Proposed Rule	Date	FR Citation
Proposed Rule: Adds poison ivy, oak, sumac and insect bite indications	10/3/1989	54FR40818

External Analgesic Drug Products: Insect Repellent

Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data	2/22/2007	72FR7941

External Analgesic Drug Products: Nonmonograph Ingredients

Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Proposed Rule: Classifies category II and III ingredients without data as non-monograph	8/25/1992	57FR38568
Correction	9/8/1992	57FR40944
Correction	11/9/1992	57FR53300
Proposed Rule: 60+ Drug Categories	6/19/2008	73FR34895
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Corrects an ingredient name	1/30/1992	57FR3526
Technical Amendment: Correct an ingredient name	10/1/1992	57FR45295
Final Rule: Classifies category II and III ingredients without data as nonmonograph	5/10/1993	58FR27636

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