FDA.reportPublic FDA data

Adult Acnomel

Product NDC
69846-911
11-digit product format
698460911
Labeler code
69846
Product ID
69846-911_56698bde-bad9-46ea-b3ee-21eb8722d49e
Type
HUMAN OTC DRUG
Nonproprietary name
Resorcinol, Sulfur
Dosage form
CREAM
Route
TOPICAL
Labeler
NUMARK BRANDS, INC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1946-10-08
Marketing end
2027-12-31
Substance
RESORCINOL; SULFUR
Active strength
20; 80 mg/g; mg/g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Adult Acnomel

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RESORCINOL20 mg/g
SULFUR80 mg/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69846-911-61Adult Acnomel36 g in 1 TUBECREAM3612
69846-911-61Adult Acnomel1 in 1 CARTONCREAM112

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 45 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amazon basics step 1 cleanser Acne treatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLC23a060f0-d379-4370-9a79-ca6e854419b42024-08-26WarningsExact identifier
application number: M006
SEYTU SpotSALICYLIC ACIDOmnilife USA, Inc.68252aa0-36cd-4380-8898-16a5e47318662024-08-23WarningsExact identifier
application number: M006
Peach Slices 3 Step Acne Starter KitSALICYLIC ACIDPeach & Lily, Inc0c8860ca-5376-4e98-a7a9-4668dff4f0aa2024-08-14WarningsExact identifier
application number: M006
PHARMA CLEAR CLEANSERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCd2c39d80-5ccd-43a8-a8bf-eba502bfdbf12024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR MOISTURIZERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCc4c08475-bafa-4bb1-92a5-e94e600862642024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR ACNE TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC6d94f911-d751-45e4-b24d-8d85c6a3cefb2024-08-13WarningsExact identifier
application number: M006
Anti-Everything Face SerumSALICYLIC ACID SERUMBentley laboratories, llC8330e61c-50ec-44a5-91d9-a97e5a9d03882024-08-05WarningsExact identifier
application number: M006
Anti-Everything Face MoisturizerSALICYLIC ACID CREAMBentley Laboratories, LLC36cb28f2-2620-4b88-811f-a2d6c1e22e792024-08-05WarningsExact identifier
application number: M006
Tucks Medicated Cooling PadsWITCH HAZELBlistex Inc1eb3c742-7104-7b47-e063-6394a90a84ba2024-08-02WarningsExact identifier
application number: M006
Replenix Gly-Sal 10-2 cleanserSALICYLIC ACIDTopiderm, Inc.00d1f8af-88de-4a14-80ec-5ee9fd38b1912024-08-02WarningsExact identifier
application number: M006
AL0076001 Alba Botanica Acnedote Deep Pore WashSALICYLIC ACIDThe Hain Celestial Group, Inc.6157c9c6-f252-5b49-e053-2991aa0ad8ed2024-07-31WarningsExact identifier
application number: M006
AL00761 Alba Botanica Acnedote Face and Body ScrubSALICYLIC ACIDThe Hain Celestial Group, Inc.c55efca6-5a5b-134b-e053-2a95a90a82452024-07-31WarningsExact identifier
application number: M006
Gly-Sal 5-2SALICYLIC ACIDTopiderm, Inc.a75e4cee-678f-4e44-9e5e-bafae1c23f9b2024-07-31WarningsExact identifier
application number: M006
Face Reality Advanced Acne MedBENZOYL PEROXIDEFace Realitye1eb8496-0611-4dbc-befb-fb43ec1644332024-07-26WarningsExact identifier
application number: M006
Face Reality 5% Advanced Acne MedBENZOYL PEROXIDEFace Reality0e52972d-b4d9-43f8-8dbb-2eec0782e0f72024-07-26WarningsExact identifier
application number: M006
Face Reality 10% Advanced Acne MedBENZOYL PEROXIDEFace Realitya214ea15-6346-4729-ba84-fbc842faf92a2024-07-26WarningsExact identifier
application number: M006
Replenix Gly-Sal 2-2SALICYLIC ACIDTopiderm, Inc.6c6bbedc-e2ee-46a0-8800-e356bdd262b02024-07-25WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Double Action Acne SerumSALICYLIC ACIDL'Oreal USA Products Incf9daadf9-a9d3-4f2d-af07-5f0b70f7803f2024-07-17WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c7164d75-75e7-494a-9595-028ecbf262762024-07-14WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.286f642f-7359-41b9-9daf-e866a87fbefa2024-07-14WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209990Acnomel 2 % / 8 % Topical CreamPSN90f80e35-095d-88f9-8ea3-0fd54f1e916c12
312793resorcinol 2 % / sulfur 8 % Topical CreamPSN90f80e35-095d-88f9-8ea3-0fd54f1e916c12
209990resorcinol 20 MG/ML / sulfur 80 MG/ML Topical Cream [Acnomel]SBD90f80e35-095d-88f9-8ea3-0fd54f1e916c12
312793resorcinol 20 MG/ML / sulfur 80 MG/ML Topical CreamSCD90f80e35-095d-88f9-8ea3-0fd54f1e916c12
209990Acnomel 2 % / 8 % Topical CreamSY90f80e35-095d-88f9-8ea3-0fd54f1e916c12
312793resorcinol 2 % / sulfur 8 % Topical CreamSY90f80e35-095d-88f9-8ea3-0fd54f1e916c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69846-911-61698460911611 TUBE in 1 CARTON (69846-911-61) / 36 g in 1 TUBE1 tube1946-10-082027-12-31NoNoCurrent