Pain-A-Trate

Product NDC: 54473-150
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54473-150		I	Inactivated by FDA	2026-10-16
excluded package	package	54473-150	54473-150-01	I	Inactivated by FDA	2026-10-16
excluded package	package	54473-150	54473-150-03	I	Inactivated by FDA	2026-10-16

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 · 54 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54473-150-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54473-150-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54473-150-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54473-150-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-150-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54473-150-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-150-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54473-150-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-150-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54473-150-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-150-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54473-150-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-150-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54473-150-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-150-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54473-150-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-150-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54473-150-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54473-150-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54473-150-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54473-150-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54473-150-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54473-150-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54473-150-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54473-150-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54473-150-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54473-150-03	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54473-150-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54473-150-03	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54473-150-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54473-150-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54473-150-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54473-150-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54473-150-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54473-150-03	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54473-150-01	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
54473-150-01	2022-01-28	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-03	2022-01-28	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-01	2020-03-19	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-03	2020-03-19	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-01	2020-01-31	Pain-A-Trate Extra Strength Pain-Relieving Cream
54473-150-03	2020-01-31	Pain-A-Trate Extra Strength Pain-Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54473-150-01	Pain-A-TrateExtra Strength Pain-Relieving	28 g in 1 TUBE	CREAM	28		5
54473-150-03	Pain-A-TrateExtra Strength Pain-Relieving	85 g in 1 TUBE	CREAM	85		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Carbomer Copolymer Type B	INACTIVE INGREDIENT	1G56KV7BUJ	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Sorbitan monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Tea Tree Oil	INACTIVE INGREDIENT	VIF565UC2G	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	PAIN-A-TRATE (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54473-150	PAIN-A-TRATE EXTRA STRENGTH PAIN-RELIEVING (CAMPHOR AND MENTHOL AND METHYL SALICYLATE) CREAM [MELALEUCA, INC.]	5	Legacy NDC, 2 package rows	20200320_cb23ed39-eba2-412b-8737-0218b87d1669.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1091381	camphor 3.25 % / menthol 1.5 % / methyl salicylate 15 % Topical Cream	PSN	cb23ed39-eba2-412b-8737-0218b87d1669	5
1091381	camphor 32.5 MG/ML / menthol 15 MG/ML / methyl salicylate 150 MG/ML Topical Cream	SCD	cb23ed39-eba2-412b-8737-0218b87d1669	5
1091381	camphor 3.25 % / menthol 1.5 % / methyl salicylate 15 % Topical Cream	SY	cb23ed39-eba2-412b-8737-0218b87d1669	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54473-150-01	54473015001	28 g in 1 TUBE (54473-150-01)	28 g	2018-01-01	0000-00-00	No	No	Current
54473-150-03	54473015003	85 g in 1 TUBE (54473-150-03)	85 g	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pain-A-Trate Extra Strength Pain-Relieving Cream	Melaleuca, Inc. \| Melaleuca, Inc	2020-03-19	HUMAN OTC DRUG LABEL	5