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 53 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Asepxia Charcoal Acne BarSALICYLIC ACIDGenomma Lab USAf727d947-fa91-47ae-8ea5-948afc9e5ba82023-11-06WarningsExact identifier
application number: M006
Asepxia Oil-Free Acne BarSALICYLIC ACIDGenomma Lab USA0b3a9224-f250-45e9-a1fe-a54940c6f93b2023-11-06WarningsExact identifier
application number: M006
Asepxia Softening Acne BarSALICYLIC ACIDGenomma Lab USA9cf65052-b21a-42af-b45a-6a6db36fbb452023-11-06WarningsExact identifier
application number: M006
Asepxia Scrub Acne BarSALICYLIC ACIDGenomma Lab USA361a0b50-360e-4d9b-9780-16b02a2bee3c2023-11-06WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Pore Purifying TonerSALICYLIC ACIDFarmasi US LLCb8dcfaab-8c55-f23d-e053-2a95a90a8a012023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Clear Complexion CleanserSALICYLIC ACIDFarmasi US LLCb8dd3370-fe03-f0f4-e053-2a95a90ab8132023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Blemish Control SerumSALICYLIC ACIDFarmasi US LLCb8dd63d7-4ff2-60bc-e053-2a95a90ad16c2023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Clear Complexion CleanserSALICYLIC ACIDFarmasi US LLCde493e30-d10c-9def-e053-2995a90ae49a2023-11-05WarningsExact identifier
application number: M006
SERIOUS SKINCARE Continuously Clear Clearz ItBENZOYL PEROXIDEFlageoli Limitedaf4c68ef-89a8-479a-a7b1-9b005193383e2023-11-05WarningsExact identifier
application number: M006
HUMANE ACNE WASHBENZOYL PEROXIDEApprendista, LLC1d25fb25-a3d2-4c6b-a975-be7b90b702652023-11-05WarningsExact identifier
application number: M006
VIE NATURELLE ACNE BODYBENZOYL PEROXIDETNT PRO SERIES0278251d-bcf1-4177-8a57-163bd0f2df002023-11-05WarningsExact identifier
application number: M006
enfuselle Acne ClarifyingSALICYLIC ACIDShaklee Corporationdd429a9b-5c2d-4310-8506-6487b02e38802023-11-03WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Exfoliating tonerSALICYLIC ACIDPeach & Lily Inc.ba70ed1c-83cb-5eaa-e053-2a95a90a92cc2023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Clarifying CleanserSALICYLIC ACIDPeach & Lily, Inc.ba70f2b9-7a34-065c-e053-2a95a90a6eb22023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Oil Acne Free MoisturizerSALICYLIC ACIDPeach & Lily, Inc.ba70e7cf-af86-6a7f-e053-2995a90af9622023-10-28WarningsExact identifier
application number: M006
Modesa Acne TreatmentBENZOYL PEROXIDEZhejiang Jingwei Pharmaceutic Al Co., Ltd.dbfe8b9e-e343-4ed5-bd81-01b27b4aa9122023-10-27WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEVivier Pharma, Inc.b4844539-bdd2-42a6-b946-6028de4f3cf12023-10-27WarningsExact identifier
application number: M006
Acne Treatment SystemBENZOYL PEROXIDE, SALICYLIC ACIDVivier Pharma, Inc.d39ee6a2-5d65-4198-82d9-deb83471f3122023-10-27WarningsExact identifier
application number: M006
Equate Beauty Quick Action Pads Salicylic Acid Acne TreatmentSALICYLIC ACIDBath Concept Cosmetics (Dongguan) Co., Ltdc94e85a7-b799-b70d-e053-2a95a90aaee22023-10-26WarningsExact identifier
application number: M006
ARTISTRY STUDiO Rose All Day Anti Acne Toner Pore RefresherSALICYLIC ACIDAccess Business Group LLCa9e26804-7989-41d2-8506-c4b65ca385b72023-10-21WarningsExact 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