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 52 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Fighting Spot with Aloe clearSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.db0054b1-29b9-48fa-8a02-86683bae81342023-11-21WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Clarifying Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.9add83f2-7da6-4cd0-b91b-f6c937a562552023-11-20WarningsExact identifier
application number: M006
Dr. Gross AB Acne Daily BreakoutSALICYLIC ACIDTopiderm, Inc79d7f1f6-d08f-4be0-afc1-9ab4338a954d2023-11-20WarningsExact identifier
application number: M006
Dr. Dennis Gross Alpha Beta On the Spot EliminatorSALICYLIC ACIDTopiderm, Ince0dccdbc-56fd-4034-b479-f2a2ebde22342023-11-16WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Triple-Action Acne SerumSALICYLIC ACIDGalderma Laboratories, L.P.3e6eb59f-c523-460e-87ed-750b4a8cacac2023-11-16WarningsExact identifier
application number: M006
Medicated WashSALICYLIC ACIDVivier Pharma, Inc.e90ab8b6-6a77-4e02-9d71-45cd7383cb0a2023-11-14WarningsExact identifier
application number: M006
GOODBYE ACNE Complete treatment gelSALICYLIC ACIDPeter Thomas Roth, LLC09b88031-f5fe-8ae1-e063-6394a90a8a6a2023-11-14WarningsExact identifier
application number: M006
L BRI Pure n Natural Deep Clean TonerSALICYLIC ACIDL'BRI HEALTH AND BEAUTY INC353e948e-da5d-4c15-adcb-77ef978cf05f2023-11-11WarningsExact identifier
application number: M006
MD-Acne Body Acne TreatmentBENZOYL PEROXIDEMD Algorithms Inc.97981e9b-d56a-42f6-a75f-647b4732021e2023-11-11WarningsExact identifier
application number: M006
ACNE THERAPYBENZOYL PEROXIDEmenScience Androceuticals, LLC4dec259d-200e-44f2-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M006
HUMANE Acne Spot TreatmentBENZOYL PEROXIDEApprendista, LLCceeb398e-c516-45e4-a21c-cbecf6206fcc2023-11-11WarningsExact identifier
application number: M006
VANIBISS BUTT and THIGHS Acne Treatment CreamSALICYLIC ACIDVanibiss Inca0a75b54-e484-4e89-bdf2-e2c864cd27342023-11-11WarningsExact identifier
application number: M006
SIMPLY VITAL Acne Face CreamSALICYLIC ACIDALPHA PLANTS INC67c43d4a-873c-4b8e-83ff-6485d9633e7b2023-11-11WarningsExact identifier
application number: M006
CLARIFAST One Step Acne TreatmentSALICYLIC ACIDVIREO SYSTEMS, INC.b20a0f00-4bf2-4583-b399-7097542fff902023-11-11WarningsExact identifier
application number: M006
5 Percent Benzoyl Peroxide CleanserBENZOYL PEROXIDEBrand Evangelists for Beauty Limitede82469e2-606a-4263-9aaa-08596b59ff6b2023-11-10WarningsExact identifier
application number: M006
The INKEY List Acne Clearing MoisturizerSULFURBrand Evangelists for Beauty Limitedd26f5031-6592-4467-afc9-41c21f9f048c2023-11-10WarningsExact identifier
application number: M006
ACNE FORTE Acne Treatment CreamBENZOYL PEROXIDEGSCM Ventures Inc. DBA Revitolc29ed6c1-b8ad-4131-a94c-379f16ab2ee52023-11-10WarningsExact identifier
application number: M006
Meijer Blackhead Clearing Scrub Acne medicationSALICYLIC ACIDMeijer Distribution, Inc338e8937-e17e-4e14-b18f-2e63f55314422023-11-08WarningsExact identifier
application number: M006
Acne Fighting Foundation CaramelSALICYLIC ACIDZhejiang Ayan Biotech Co.,Ltd.92c4fe5f-fcc8-4dde-9f34-a55f53e009bb2023-11-06WarningsExact identifier
application number: M006
Asepxia Neutral Acne BarSALICYLIC ACIDGenomma Lab USAb3995e68-d364-4d96-8148-b456087b42972023-11-06WarningsExact 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