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 38 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TREAT SO DEEP ACNE-FIGHTING TREATMENTSALICYLIC ACIDASPIRE BRANDS INCd18b4f15-9ea1-4d76-a1e3-a0be1c5bb58a2024-12-06WarningsExact identifier
application number: M006
Oxy Maximum Strength Rapid Spot TreatmentOXY MAXIMUM STRENGTH RAPID SPOT TREATMENTThe Mentholatum Company28886273-a71a-46ea-e063-6394a90ac11d2024-12-05WarningsExact identifier
application number: M006
Dermaclear Spot TreatmentBENZOYL PEROXIDEAllure Labs Inc45a93c47-552f-4660-a37c-7a8cceac2d8e2024-12-05WarningsExact identifier
application number: M006
DermaClear PadsSALICYLIC ACIDAllure Labs0c6624fd-88f9-402c-8ac2-bc278242b4842024-12-05WarningsExact identifier
application number: M006
DermaClear BHA Spot TreatmentSALICYLIC ACIDAllure Labsb629cb05-548e-4d60-e053-2a95a90aeefb2024-12-05WarningsExact identifier
application number: M006
Acne Treatment Maximum StrengthSALICYLIC ACIDYoung Living Essential Oils, LC756a52ff-161d-4b6e-933b-49bce885d9982024-12-04WarningsExact identifier
application number: M006
DermaClear SerumSALICYLIC ACIDAllure Labs Inc487a7d1c-0f98-4d36-bfe9-c12bcda8d0b32024-12-04WarningsExact identifier
application number: M006
Dermaclear MaskSALICYLIC ACIDAllure Labs Inc,9429f477-a916-49c9-bf04-1cf591af5c7f2024-12-04WarningsExact identifier
application number: M006
Clear System Clarifying Gel CleanserSALICYLIC ACIDBentley Laboratories, LLC08248e40-aa71-4dfb-8a75-af8886ccb9762024-12-04WarningsExact identifier
application number: M006
DermaClear BHA CleanserSALICYLIC ACIDAllure Labs Incbfeced33-a630-4f1d-9ecf-33450bd26ae92024-12-03WarningsExact identifier
application number: M006
PCA SKIN Intensive Clarity TreatmentSALICYLIC ACIDCP Skin Health Group, Inc.7bd6edc0-941e-492d-8b3c-4e8b3425f9292024-12-03WarningsExact identifier
application number: M006
PCA SKIN BPO CleanserBENZOYL PEROXIDECP Skin Health Group, Inc.eb55cc26-cf47-4e9e-b7a8-23ef82aecce22024-12-03WarningsExact identifier
application number: M006
PCA SKIN AcneBENZOYL PEROZIDECP Skin Health Group, Inc.257bd9dd-93f9-4996-8478-8198be3ef6832024-12-03WarningsExact identifier
application number: M006
PCA GelSALICYLIC ACIDCP Skin Health Group, Inc396b4675-451f-48b2-b139-19508434e0fe2024-12-03WarningsExact identifier
application number: M006
CliniCalmHYDROCORTISONECP Skin Health Group, Inc.febcf7e8-668c-a5c9-e053-6394a90aec392024-12-03WarningsExact identifier
application number: M006
Alumier MD Acne Clarifying CleanserSALICYLIC ACIDAlumier Labs87747f82-9018-ab34-e053-2995a90a68082024-12-01WarningsExact identifier
application number: M006
Acne Control Face WashSALICYLIC ACIDBentley Laboratories, LLC068c5fef-cdc5-49f4-9372-9cfdd07508b82024-11-28WarningsExact identifier
application number: M006
Acne Control Body WashSALICYLIC ACIDBentley Laboratories, LLC3db0f885-4c08-4678-8533-ba2025bf7d482024-11-28WarningsExact identifier
application number: M006
Neutrogena Stubborn Blackheads Daily SerumSALICYLIC ACIDKenvue Brands LLCc0992ceb-5f7a-4c8f-a43f-7a300bd6bbf12024-11-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Acne Spot DryingSULFURKenvue Brands LLCdffe9bf4-a8a2-4fa0-e053-2995a90abcb32024-11-26WarningsExact 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