FDA.reportPublic FDA data

Analgesic Creme Rub

Product NDC
0904-5857
11-digit product format
009045857
Labeler code
0904
Product ID
0904-5857_a1631071-3e88-44d8-b74f-56a4821062ee
Type
HUMAN OTC DRUG
Nonproprietary name
Trolamine Salicylate 10%
Dosage form
CREAM
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-05-10
Marketing end
0000-00-00
Substance
TROLAMINE SALICYLATE
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct0904-5857DDiscontinued by firm2026-08-11
excluded packagepackage0904-58570904-5857-56DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-5857-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-5857-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-5857-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-5857-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-5857-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-5857-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-5857-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-5857-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-5857-560efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-5857-56ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-5857-56367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-5857-56557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5857-56GM - Gram0904-5857df0cd16e-78c8-43ca-ae1a-70200b9a871712014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TROLAMINE SALICYLATEACTIVE INGREDIENTH8O4040BHDANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
POTASSIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTCI71S98N1ZANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
TRIETHANOLAMINE HYDROCHLORIDEINACTIVE INGREDIENTR297UJ9QDYANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RANALGESIC CREME RUB (TROLAMINE SALICYLATE 10%) CREAM [MAJOR PHARMACEUTICALS]1