Pain-A-Trate

Product NDC
54473-150
Requested package NDC
54473-150-03
11-digit product format
544730150
Labeler code
54473
Product ID
54473-150_a13d2b4d-ea05-3209-e053-2995a90ae140
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor and Menthol and Methyl Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
Melaleuca, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-05-01
Marketing end
0000-00-00
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
33 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage54473-15054473-150-03IInactivated by FDA2026-10-16

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-150-01Pain-A-TrateExtra Strength Pain-Relieving28 g in 1 TUBECREAM285
54473-150-03Pain-A-TrateExtra Strength Pain-Relieving85 g in 1 TUBECREAM855

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
MENTHOLACTIVE INGREDIENTL7T10EIP3APAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
MENTHOLACTIVE MOIETYL7T10EIP3APAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
Benzyl AlcoholINACTIVE INGREDIENTLKG8494WBHPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
Carbomer Copolymer Type BINACTIVE INGREDIENT1G56KV7BUJPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
Glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YHPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
Sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
Tea Tree OilINACTIVE INGREDIENTVIF565UC2GPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
TrolamineINACTIVE INGREDIENT9O3K93S3TKPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RPAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-150PAIN-A-TRATE EXTRA STRENGTH PAIN-RELIEVING (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]5Legacy NDC, 2 package rows20200320_cb23ed39-eba2-412b-8737-0218b87d1669.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091381camphor 3.25 % / menthol 1.5 % / methyl salicylate 15 % Topical CreamPSNcb23ed39-eba2-412b-8737-0218b87d16695
1091381camphor 32.5 MG/ML / menthol 15 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDcb23ed39-eba2-412b-8737-0218b87d16695
1091381camphor 3.25 % / menthol 1.5 % / methyl salicylate 15 % Topical CreamSYcb23ed39-eba2-412b-8737-0218b87d16695

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54473-150-035447301500385 g in 1 TUBE (54473-150-03) 85 g2018-01-010000-00-00NoNoCurrent