Theragesic

Product NDC: 0178-0320
11-digit product format: 001780320
Labeler code: 0178
Product ID: 0178-0320_462d3c9c-2c14-0f71-e063-6294a90a0f40
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: 2026-12-31
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: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LAV5U5022Y	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
259203	Internal RxNorm lookup
724160	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
db6c0c77-0a20-d574-a98f-e6c9998b941f	Available on FDA.report

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 7 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cortizone 10 Itch Relief Massaging Rollerball	HYDROCORTISONE	Chattem, Inc.	1e27682c-f856-41f1-9935-37540960a4c7	2026-07-31	Warnings	Exact identifier application number: M017
Aspercreme with Lidocaine Dry	LIDOCAINE	Chattem, Inc.	008abaaa-5e12-4246-a7f5-66f3966acf28	2026-07-30	Warnings	Exact identifier application number: M017
ACOLYE Lidocaine Cream Topical Analgesia Cream	LIDOCAINE,MENTHOL	Guangdong Aimu Biological Technology Co., Ltd	57deebf7-52f1-4256-e063-6294a90a75d5	2026-07-30	Warnings	Exact identifier application number: M017
Icy Hot Performance No-Mess Pain Relief Cream	MENTHOL 16%, CAMPHOR 11%	Chattem, Inc.	5e3e272a-c001-4f57-9535-521ccc85ae65	2026-07-30	Warnings	Exact identifier application number: M017
Auixudin Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bc7b9e-e2f7-724b-e063-6394a90ab36f	2026-07-29	Warnings	Exact identifier application number: M017
Jinfahe Lidocaine Pain Relief Patch	LIDOCAINE PAIN RELIEF PATCH	Henan Enokon Medical Instrument Co., Ltd.	57bcd9c5-767e-b634-e063-6394a90a2878	2026-07-29	Warnings	Exact identifier application number: M017
Maximun Strength Lidocaine Patch Plus Menthol	LIDOCAINE, MENTHOL	Meijer Distribution Inc	d0468514-58ea-4d8f-b634-a65bf95c0316	2026-07-29	Warnings	Exact identifier application number: M017
Oudetas Lidocaine Cream	LIDOCAINE CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	57ca9220-2778-790a-e063-6294a90af506	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine No-Mess plus Lavender	LIDOCAINE HCL	Chattem, Inc.	3948a3d2-ce04-4703-8709-211e75c9c38d	2026-07-29	Warnings	Exact identifier application number: M017
Aspercreme Professional Cream	LIDOCAINE HCL 4%	Chattem, Inc.	ef297864-5917-4645-8ec7-f2bc49e037e8	2026-07-29	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Clinic Pharma	cdfd6b39-b430-4e95-a0f7-682cf3d78b52	2026-07-28	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Clinic Pharma	2b4d2105-b7ad-2695-e063-6394a90a999b	2026-07-28	Warnings	Exact identifier application number: M017
HEMPE Ice Muscle and Joint Gel	MENTHOL	Healthcare International Research Limited	57aec922-1de4-c579-e063-6394a90af6c8	2026-07-28	Warnings	Exact identifier application number: M017
Earths Care Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	DLC Laboratories, Inc.	5c3976da-a6cb-4b94-ae41-3e86b1ab13cb	2026-07-28	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Preferred Pharmaceuticals Inc.	9e7568b6-52ae-4f7a-9bfd-503fd80a297e	2026-07-28	Warnings	Exact identifier application number: M017
Aspercreme Lidocaine with Rosemary and Mint	LIDOCAINE HYDROCHLORIDE	Chattem, Inc.	9d40bfea-85d0-4943-83e9-0c16e79a011c	2026-07-28	Warnings	Exact identifier application number: M017
KENS PAIN AND ARTHRITIS FORMULA	MENTHOL	Eezaway Relief Inc	35834473-3ad5-41ec-a110-e742aa7e2ee4	2026-07-28	Warnings	Exact identifier application number: M017
DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream	LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57935b64-6e2e-85d0-e063-6394a90a7428	2026-07-27	Warnings	Exact identifier application number: M017
1% Hydrocortisone Anti-itch	1% HYDROCORTISONE ANTI-ITCH	ALAINA HEALTHCARE PRIVATE LIMITED	b8416467-55f7-4e5f-a5cb-3abd3e2bb577	2026-07-27	Warnings	Exact identifier application number: M017
OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH	MENTHOL	OWELL NATURAL 8 LLC	57984bc2-bf1d-c423-e063-6394a90a06ae	2026-07-27	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	0000-00-00	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