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 54 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Burn Cream	FIRST AID BURN CREAM	ProStat First Aid LLC	0037a1a4-d747-2567-e063-6394a90a721c	2025-12-15	Warnings	Exact identifier application number: M017
PS-3885 Burn Ease, 3.5g	PS-3885 BURN EASE, 3.5G	ProStat First Aid LLC	004c6deb-2844-a0d0-e063-6394a90ae5e4	2025-12-15	Warnings	Exact identifier application number: M017
2677 First Aid Burn Cream	2677 FIRST AID BURN CREAM	ProStat First Aid LLC	ff5bb628-8ef7-4540-e053-6394a90a55ed	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	ProStat First Aid LLC	f71b98b4-22d0-0124-e053-6394a90ae4cf	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	ProStat First Aid LLC	f71eb4f5-2280-5867-e053-6394a90aac57	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease 3.5g	BURN EASE 3.5G	Front Line Safety	0f8e6842-c889-d5d3-e063-6394a90af880	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease 3.5g	BURN EASE 3.5G	Front Line Safety	0f8c59fb-3622-2bb7-e063-6294a90adc6e	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	Front Line Safety	0e34cb09-d8c6-f8c0-e063-6294a90a0be0	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease 3.5g	BURN EASE 3.5G	Front Line Safety	0f52021f-af8a-5b95-e063-6294a90a2c2a	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	ProStat First Aid LLC	0e25c936-e40a-e23c-e063-6294a90ac0e4	2025-12-15	Warnings	Exact identifier application number: M017
Sting Relief Wipes	STING RELIEF WIPES	ProStat First Aid LLC	0e20252a-5ecb-2526-e063-6294a90a8cde	2025-12-15	Warnings	Exact identifier application number: M017
First Aid Burn Cream	FIRST AID BURN CREAM	Front Line Safety	0f4ce2c2-f306-d95f-e063-6394a90ae7b3	2025-12-15	Warnings	Exact identifier application number: M017
Magsoothium Body	MENTHOL, CAPSAICIN	Ubu/Elements, Inc.	f604d30c-b17c-ec01-e053-2a95a90aa304	2025-12-15	Warnings	Exact identifier application number: M017
Salonpas pain relieving JET	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	dd1ea3bf-891a-402e-8f43-14302bc9c3e5	2025-12-15	Warnings	Exact identifier application number: M017
Herbal Tendon Bone Relief	CAMPHOR MINT	Guchutang Biotechnology (Longyan) Co., Ltd.	45cf4040-9751-d24b-e063-6294a90aff27	2025-12-13	Warnings	Exact identifier application number: M017
ElixirLidoFast	LIDOCAINE 5% CREAM	ELIXIR HEALTHCARE USA, LLC.	45de5a3d-06c2-aa02-e063-6294a90a63d3	2025-12-13	Warnings	Exact identifier application number: M017
MEDI FIRST PLUS	HYDROCORTISONE ACETATE	Orazen Inc	5781124a-60f4-4a64-80b7-ce5f28d495b5	2025-12-12	Warnings	Exact identifier application number: M017
MEDI-FIRST	HYDROCORTISONE ACETATE	Orazen Inc	aeffd85c-58a7-4d64-bf94-977b6fbbe713	2025-12-12	Warnings	Exact identifier application number: M017
Joint and Muscle Relief	MENTHOL	Smart Cookie Solutions Inc.	45c24d56-4dc9-2884-e063-6294a90a52cc	2025-12-12	Warnings	Exact identifier application number: M017
Popstar	DELAY SPRAY	Pineapple Brands LLC	293b2da9-1261-0358-e063-6394a90aa08c	2025-12-12	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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1421026	menthol / methyl salicylate Paste	menthol / methyl salicylate Paste	SCDF Obsolete

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

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
0178-0320-33	00178032033	1 TUBE in 1 CARTON (0178-0320-33) / 85 g in 1 TUBE	1 tube	2026-10-26		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
THERA-GESIC ® DUAL-ACTION PAIN RELIEVING CREAM	Mission Pharmacal Company	2026-10-19	HUMAN OTC DRUG LABEL	1
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

Theragesic

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

Additional Listing Data#

Active Ingredients#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#