Theragesic

Product NDC: 0178-0320
11-digit product format: 001780320
Labeler code: 0178
Product ID: 0178-0320_5dd38d22-1f8c-c8ad-e063-6294a90abfe7
Type: HUMAN OTC DRUG
Nonproprietary name: METHYL SALICYLATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Mission Pharmacal Company
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1981-01-01
Substance: METHYL SALICYLATE; MENTHOL
Active strength: 150; 10 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 12 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
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	0178-0320-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0178-0320-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0178-0320-16	`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	0178-0320-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0178-0320-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0178-0320-16	`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	0178-0320-05	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0178-0320-03	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0178-0320-16	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Theragesic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYL SALICYLATE	150 mg/g
MENTHOL	10 mg/g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0178-0320-03	2023-08-31	THERA-GESIC ® Creme
0178-0320-03	2023-08-31	THERA-GESIC ® Creme
0178-0320-05	2023-08-31	THERA-GESIC ® Creme
0178-0320-05	2023-08-31	THERA-GESIC ® Creme
0178-0320-16	2023-08-31	THERA-GESIC ® Creme
0178-0320-16	2023-08-31	THERA-GESIC ® Creme
0178-0320-03	2022-01-28	THERA-GESIC ® Creme
0178-0320-03	2022-01-28	THERA-GESIC ® Creme
0178-0320-05	2022-01-28	THERA-GESIC ® Creme
0178-0320-05	2022-01-28	THERA-GESIC ® Creme
0178-0320-16	2022-01-28	THERA-GESIC ® Creme
0178-0320-16	2022-01-28	THERA-GESIC ® Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0178-0320-03	Theragesic	85 g in 1 TUBE	CREAM	85		7
0178-0320-03	Theragesic	1 in 1 CARTON	CREAM	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-0320-03	GM - Gram	0178-0320	328cb5be-ae2e-4347-ae09-ab2e2f5e9e07	1	2013-10-17
0178-0320-05	GM - Gram	0178-0320	0624c2d0-415a-49c3-a0bb-c0826bc8e28e	1	2013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	Z135WT9208	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0178-0320	THERAGESIC (METHYL SALICYLATE) CREAM [MISSION PHARMACAL COMPANY]	6	Current NDC, Legacy NDC, 2 package rows	20240320_db6c0c77-0a20-d574-a98f-e6c9998b941f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 39 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Easment advanced absorption cream	CAPSAICIN 0.1%	Easment LLC	48de3ced-f67f-7c86-e063-6294a90a340c	2026-01-20	Warnings	Exact identifier application number: M017
Black Cobra Tattoo NumbingSpray 4% Lidocaine	LIDOCAINE	Foshan Sugar Max Cosmetics CO.,Ltd	3605fcbf-63c8-87b5-e063-6294a90a9c3e	2026-01-19	Warnings	Exact identifier application number: M017
Black Cobra Tattoo Numbing Cream 4% Lidocaine	LIDOCAINE	Foshan Sugar Max Cosmetics CO.,Ltd	3605961a-d596-9c4a-e063-6394a90a99dc	2026-01-19	Warnings	Exact identifier application number: M017
Bakers Best Arthritis Pain Relief	HISTAMINE DIHYDROCHLORIDE	Baker's Best Health Products, LLC	869735f9-335e-4a5e-adfc-91167ae943c5	2026-01-19	Warnings	Exact identifier application number: M017
SIMPLY VITAL PAIN RELIEF HEMP	MENTHOL	ALPHA PLANTS INC	c14f4c06-cfe5-497e-9f9e-b2ba442e61bb	2026-01-19	Warnings	Exact identifier application number: M017
AsperFlex	MENTHOL AND METHYL SALICYLATE	Akron Pharma Inc.	117de175-976d-44f3-85ed-3d127fbe3a7c	2026-01-19	Warnings	Exact identifier application number: M017
Equate Pain Relieving Ultra Strength	CAMPHOR, MENTHOL, METHYL SALICYLATE	Wal-Mart Stores Inc	5ed1d7b3-925e-4a18-8e15-636f5b442ad7	2026-01-19	Warnings	Exact identifier application number: M017
Equate Medicated Pain Relieving Patch, Large 6-Count	CAMPHOR, MENTHOL, METHYL SALICYLATE	Walmart Stores Inc	2c25cd7a-7e7b-5add-e063-6294a90a9e9b	2026-01-19	Warnings	Exact identifier application number: M017
Equate Hydrocortione	1% HYDROCORTISONE	Walmart Inc.	85b7f620-cc95-4333-b124-bbcc8fd5f7eb	2026-01-19	Warnings	Exact identifier application number: M017
GuruNanda Pain Relief	MENTHOL	GURUNANDA, LLC	3f1d146e-0d18-7f2f-e063-6394a90ab816	2026-01-19	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine	LIDOCAINE	Chattem, Inc.	7ad8efa9-7031-4cd0-be1d-6dee63091fd1	2026-01-19	Warnings	Exact identifier application number: M017
Best Choice Targeted Warming Capsaicin Heat Patch	CAPSAICIN	Valu Merchandisers Company	24ca40b7-e17b-42a3-bcc8-6861b9a5934a	2026-01-18	Warnings	Exact identifier application number: M017
TOPCARE PAIN RELIEF PATCHES	LIDOCAINE	TOPCO ASSOCIATES, LLC	fa2f7768-e779-4409-aad3-6c33ce2e6b36	2026-01-18	Warnings	Exact identifier application number: M017
Neuropathy Pain Relief Cream	MENTHOL CREAM	Owell Naturals Brand, LLC	48979093-2992-5fd8-e063-6394a90a815d	2026-01-17	Warnings	Exact identifier application number: M017
CVS Lidocaine Pain Relief Cream	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	45c4f946-13b9-7a0a-e063-6394a90a7353	2026-01-16	Warnings	Exact identifier application number: M017
TopCare Pain Relieving Cream	LIDOCAINE HCL 4%	Topco Associates, LLC	4885a7e6-a127-450a-e063-6294a90a4f91	2026-01-16	Warnings	Exact identifier application number: M017
Calmara	CALMARA	Dynarex Corporation	487393e9-6619-6033-e063-6294a90a68b2	2026-01-16	Warnings	Exact identifier application number: M017
Maximum Strength Hydrocortisone	HYDROCORTISONE OINTMENT	Walgreens	7088092c-3a5f-4fcc-84cc-931d238f7501	2026-01-15	Warnings	Exact identifier application number: M017
Itch Relief Gel	DIPHENHYDRAMINE HCL	Walgreens	487060a7-dff3-4840-b967-ca919f8d0a29	2026-01-15	Warnings	Exact identifier application number: M017
Walgreen Itch Relief Gel	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	5aca3297-406f-4165-9895-c58ccffb374f	2026-01-15	Warnings	Exact identifier application number: M017

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	db6c0c77-0a20-d574-a98f-e6c9998b941f	7
724160	THERA-GESIC Pain Relieving Creme 1 % / 15 % Topical Cream	PSN	db6c0c77-0a20-d574-a98f-e6c9998b941f	7
724160	menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical Cream [Thera-Gesic]	SBD	db6c0c77-0a20-d574-a98f-e6c9998b941f	7
259203	menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical Cream	SCD	db6c0c77-0a20-d574-a98f-e6c9998b941f	7
259203	menthol 1 % / methyl salicylate 15 % Topical Cream	SY	db6c0c77-0a20-d574-a98f-e6c9998b941f	7
724160	Thera-Gesic (menthol 10 MG/ML / methyl salicylate 150 MG/ML) Topical Cream	SY	db6c0c77-0a20-d574-a98f-e6c9998b941f	7
724160	Thera-Gesic Pain Relieving Creme (menthol 1 % / methyl salicylate 15 % ) Topical Cream	SY	db6c0c77-0a20-d574-a98f-e6c9998b941f	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0178-0320-03	00178032003	1 TUBE in 1 CARTON (0178-0320-03) / 85 g in 1 TUBE	1 tube	1981-01-01	2029-02-28	No	No	Current
0178-0320-05	00178032005	1 TUBE in 1 CARTON (0178-0320-05) > 142 g in 1 TUBE	1 tube	1981-01-01	0000-00-00	No	No	Current
0178-0320-16	00178032016	454 g in 1 BOTTLE, PLASTIC (0178-0320-16)	454 g	1981-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
THERA-GESIC ® Creme	Mission Pharmacal Company	2026-10-14	HUMAN OTC DRUG LABEL	8
THERA-GESIC ® Creme	A-S Medication Solutions	2021-04-14	HUMAN OTC DRUG LABEL	13
Theragesic Creme - Proficient Rx LP	Proficient Rx LP	2019-11-01	HUMAN OTC DRUG LABEL	3