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
0178-0320-05	2023-08-31	THERA-GESIC ® Creme
0178-0320-16	2023-08-31	THERA-GESIC ® Creme
0178-0320-03	2022-01-28	THERA-GESIC ® Creme
0178-0320-05	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 12 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Natures Willow Balm Roll On Pain Relief	MENTHOL	WB Ventures LLC	3b1834e6-75cd-5380-e063-6294a90ad1d5	2026-07-08	Warnings	Exact identifier application number: M017
Natures Willow Balm Itch Relief Cream	MENTHOL	WB Ventures LLC	0ce31b5d-4401-460c-e063-6394a90ab558	2026-07-08	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc.	560a4abf-31dd-333f-e063-6294a90a3505	2026-07-08	Warnings	Exact identifier application number: M017
Natures Willow Balm	MENTHOL	WB VENTURES LLC	b9f50c43-b0d5-39a8-e053-2995a90a04f1	2026-07-08	Warnings	Exact identifier application number: M017
Natures Willow Bug Bite Balm	MENTHOL	WB Ventures LLC	b9fab18f-32c7-d5bd-e053-2995a90a6d0f	2026-07-08	Warnings	Exact identifier application number: M017
Salonpas pain relieving hot	CAPSAICIN, MENTHOL	Hisamitsu Pharmaceutical Co., Inc.	d2aa8820-a947-404b-b617-e692fbd16502	2026-07-07	Warnings	Exact identifier application number: M017
Quali Yi Tiao Gen Pain Patch	CAPSAICIN PATCH	Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory	33154a9b-f6d0-4e95-b4cb-6b938f5dcf4d	2026-07-07	Warnings	Exact identifier application number: M017
MUYOHON Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	55caf0a5-f062-a6c3-e063-6294a90ae073	2026-07-04	Warnings	Exact identifier application number: M017
Targeted Warming Capsaicin Patch	CAPSAICIN	Army & Air Force Exchange Service	55b539f8-38c4-594e-e063-6394a90afbaa	2026-07-03	Warnings	Exact identifier application number: M017
TopCare Health Pain Relief	LIDOCAINE HYDROCHLORIDE	Topco Associates LLC	485b0671-da09-19d7-e063-6294a90aca5d	2026-07-03	Warnings	Exact identifier application number: M017
Mineral Ice Methol Pain Relief	MENTHOL 10.5 %	Sunflora Inc	6ddd9e97-f717-4d5a-9658-26449a3cc831	2026-07-02	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	AmerisourceBergen Drug Corporation	7d898e33-ded7-c9b9-e053-2a91aa0adf7c	2026-07-01	Warnings	Exact identifier application number: M017
Desert Harvest Releveum with Lidocaine	LIDOCAINE HYDROCHLORIDE	Desert Harvest, Inc	9ad514ab-a6bd-4564-8ba3-0149032ebf36	2026-07-01	Warnings	Exact identifier application number: M017
CVS No Mess Cortisone	HYDROCORTISONE	Natural Essentials, Inc.	558c94ec-95f1-eb98-e063-6394a90a1e72	2026-07-01	Warnings	Exact identifier application number: M017
MUSCLE EASE	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	03fff4bf-04ed-49a6-b40f-4d98c2b42f69	2026-07-01	Warnings	Exact identifier application number: M017
OrthoNesic Pain Relieving Gel	MENTHOL, CAMPHOR	Blaine Labs Inc.	122f60c2-f8df-4625-8bb8-a2244a261b5d	2026-07-01	Warnings	Exact identifier application number: M017
Desert Harvest RELEVEUM	LIDOCAINE	Desert Harvest Inc.	5d9010ec-d482-44ff-ba27-3bfec5a241c6	2026-06-30	Warnings	Exact identifier application number: M017
Promescent	LIDICAINE	Absorption	5b508238-3be7-4b0d-bf35-51de79f58f55	2026-06-30	Warnings	Exact identifier application number: M017
Lidovyx	LIDOCAINE 4%	V2 Pharma LLC	4465eb60-a617-4608-9504-8b3b4c64f49e	2026-06-30	Warnings	Exact identifier application number: M017
Dr.Johnes Lidocaine 4% Topical Analgesic Cream	LIDOCAINE HCL,MENTHOL	Dr.Johnes LLC	6144708d-4b0f-4f0d-88e3-6925ba2d004d	2026-06-29	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	2025-12-17	HUMAN OTC DRUG LABEL	7
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