Theragesic Creme

Product NDC: 71269-005
Requested package NDC: 71269-005-03
11-digit product format: 712690005
Labeler code: 71269
Product ID: 71269-005_9f55e38e-03bc-42fc-e053-2a95a90a1378
Type: HUMAN OTC DRUG
Nonproprietary name: METHYL SALICYLATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Mainpointe Pharmaceuticals, LLC
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 1981-01-01
Marketing end: 0000-00-00
Substance: METHYL SALICYLATE; MENTHOL
Active strength: 150 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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71269-005	71269-005-03	D	Discontinued by firm		2026-10-05

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 date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71269-005-03	2022-01-28	C162847	48780-1	d6a99b39-a1b5-a426-e053-dadaa90af4c2	THERA-GESIC ® Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71269-005-03	Theragesic Creme	85 g in 1 TUBE	CREAM	85		1
71269-005-03	Theragesic Creme	1 in 1 CARTON	CREAM	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71269-005-03	GM - Gram	71269-005	3d1898ac-7853-4892-a1a8-c7368bbc2a2e	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71269-005	THERAGESIC CREME (METHYL SALICYLATE) CREAM [MAINPOINTE PHARMACEUTICALS, LLC]	1	Legacy NDC, 2 package rows	20200225_9f55e38e-03bb-42fc-e053-2a95a90a1378.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
259203	menthol 1 % / methyl salicylate 15 % Topical Cream	PSN	9f55e38e-03bb-42fc-e053-2a95a90a1378	1
724160	THERA-GESIC Pain Relieving Creme 1 % / 15 % Topical Cream	PSN	9f55e38e-03bb-42fc-e053-2a95a90a1378	1
724160	menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical Cream [Thera-Gesic]	SBD	9f55e38e-03bb-42fc-e053-2a95a90a1378	1
259203	menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical Cream	SCD	9f55e38e-03bb-42fc-e053-2a95a90a1378	1
259203	menthol 1 % / methyl salicylate 15 % Topical Cream	SY	9f55e38e-03bb-42fc-e053-2a95a90a1378	1
724160	Thera-Gesic (menthol 10 MG/ML / methyl salicylate 150 MG/ML) Topical Cream	SY	9f55e38e-03bb-42fc-e053-2a95a90a1378	1
724160	Thera-Gesic Pain Relieving Creme (menthol 1 % / methyl salicylate 15 % ) Topical Cream	SY	9f55e38e-03bb-42fc-e053-2a95a90a1378	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71269-005-03	71269000503	1 TUBE in 1 CARTON (71269-005-03) > 85 g in 1 TUBE	1 tube	2018-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
THERA-GESIC ® Creme	Mainpointe Pharmaceuticals, LLC \| Mission Pharmacal Company	2020-02-20	HUMAN OTC DRUG LABEL	1