FDA.reportPublic FDA data

BUTT AND THIGHS

Product NDC
82767-002
11-digit product format
827670002
Labeler code
82767
Product ID
82767-002_eaebf4b4-ba4d-15ad-e053-2a95a90ab5ac
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Teamtrade Inc.
Application
M006
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-09-22
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct82767-002IInactivated by FDA2026-10-16
excluded packagepackage82767-00282767-002-04IInactivated by FDA2026-10-16

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82767-002-04BUTT AND THIGHSACNE TREATMENT118.3 mL in 1 TUBECREAM118.33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82767-002BUTT AND THIGHS ACNE TREATMENT (SALICYLIC ACID) CREAM [TEAMTRADE INC.]3Legacy NDC, 1 package rows20231103_e94a3d17-564f-3e64-e053-2995a90aa402.zip

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 55 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Replenix Acne Gly-Sal 2-2 Foaming CleanserSALICYLIC ACIDTopiderm, Inc.811dbf95-2b39-45c5-99a2-33c3c9d195702019-12-19WarningsExact identifier
application number: M006
REPLENIX ACNE SOLUTIONS WASHBENZOYL PEROXIDETopiderm, Inc.8dc2d27d-3cc4-4874-b4c2-32607849b2052019-12-17WarningsExact identifier
application number: M006
REPLENIX ACNE Solution BENZOYL PEROXIDE WASHBENZOYL PEROXIDETopiderm, Inc.235e9dd5-13f2-4078-9807-1d87fd9e6cba2019-12-17WarningsExact identifier
application number: M006
Replenix AcneBENZOYL PEROXIDETopiderm, Inc03d4c298-8f44-41f7-b086-96ae836152bb2019-10-31WarningsExact identifier
application number: M006
Replenix AcneBENZOYL PEROXIDETopiderm, Inc.c12f9005-a549-4447-9beb-df7126f77df12019-10-31WarningsExact identifier
application number: M006
Gly-Sal 10-2 PadsSALICYLIC ACIDTopiderm, Inc.b39e845d-4c40-4f9e-9cb5-a8386f3266522019-10-23WarningsExact identifier
application number: M006
Gly-Sal 5-2 PadsSALICYLIC ACIDTopiderm, Inc.e73bd26c-cdc2-47ab-94e8-3bc49a9b19e82019-10-22WarningsExact identifier
application number: M006
SKIN MEDICA Purifying Foaming WashSALICYLIC ACIDAllergan, Inc.064d9e2b-077f-4229-b653-666fc5479ae22013-03-01WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSNe94a3d17-564f-3e64-e053-2995a90aa4023
317152salicylic acid 20 MG/ML Topical CreamSCDe94a3d17-564f-3e64-e053-2995a90aa4023
317152salicylic acid 2 % Topical CreamSYe94a3d17-564f-3e64-e053-2995a90aa4023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82767-002-0482767000204118.3 mL in 1 TUBE (82767-002-04) 118.3 ml2022-09-220000-00-00NoNoCurrent