FDA.reportPublic FDA data

AZELAIC ACID BHA SPOT TREATMENT

Product NDC
61328-401
11-digit product format
613280401
Labeler code
61328
Product ID
61328-401_ceba6d29-4a0f-eba5-e053-2995a90ad5c0
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Skinfix, Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-03-16
Marketing end
0000-00-00
Substance
SALICYLIC ACID
Active strength
2 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61328-401DDiscontinued by firm2026-07-31
excluded packagepackage61328-40161328-401-05DDiscontinued by firm2026-07-31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61328-401-056132804010515 mL in 1 TUBE (61328-401-05) 15 ml2021-03-160000-00-00NoNoCurrent