FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0178-0320-05fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0178-0320-03fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0178-0320-16fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0178-0320-0586f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0178-0320-0386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage0178-0320-1686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0178-0320-05bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0178-0320-03bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage0178-0320-16bd6a592717d7…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
IngredientStrength
METHYL SALICYLATE150 mg/g
MENTHOL10 mg/g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0178-0320-032023-08-31THERA-GESIC ® Creme
0178-0320-032023-08-31THERA-GESIC ® Creme
0178-0320-052023-08-31THERA-GESIC ® Creme
0178-0320-052023-08-31THERA-GESIC ® Creme
0178-0320-162023-08-31THERA-GESIC ® Creme
0178-0320-162023-08-31THERA-GESIC ® Creme
0178-0320-032022-01-28THERA-GESIC ® Creme
0178-0320-032022-01-28THERA-GESIC ® Creme
0178-0320-052022-01-28THERA-GESIC ® Creme
0178-0320-052022-01-28THERA-GESIC ® Creme
0178-0320-162022-01-28THERA-GESIC ® Creme
0178-0320-162022-01-28THERA-GESIC ® Creme

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0320-03Theragesic85 g in 1 TUBECREAM857
0178-0320-03Theragesic1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0320-03GM - Gram0178-0320328cb5be-ae2e-4347-ae09-ab2e2f5e9e0712013-10-17
0178-0320-05GM - Gram0178-03200624c2d0-415a-49c3-a0bb-c0826bc8e28e12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ATHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ATHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YTHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YTHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
MENTHOLACTIVE MOIETYL7T10EIP3ATHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
MENTHOLACTIVE MOIETYL7T10EIP3ATHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZTHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZTHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208THERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208THERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OTHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OTHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKTHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKTHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1
WaterINACTIVE INGREDIENT059QF0KO0RTHERAGESIC CREME (METHYL SALICYLATE) GEL [MISSION PHARMACAL COMPANY]1
WaterINACTIVE INGREDIENT059QF0KO0RTHERAGESIC CREME (METHYL SALICYLATE) GEL [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0320THERAGESIC (METHYL SALICYLATE) CREAM [MISSION PHARMACAL COMPANY]6Current NDC, Legacy NDC, 2 package rows20240320_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 45 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact identifier
application number: M017
Lidocaine 4% Topical Anesthetic CreamLIDOCAINE 4%Oncor Pharmaceuticals1baaa669-05af-4024-a0ba-ee3451756f6a2026-01-05WarningsExact identifier
application number: M017
TheraCare Pain ReliefMENTHOLVeridian Healthcare6834a6de-4d1d-4e40-945d-ec5c267abd142026-01-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259203menthol 1 % / methyl salicylate 15 % Topical CreamPSNdb6c0c77-0a20-d574-a98f-e6c9998b941f7
724160THERA-GESIC Pain Relieving Creme 1 % / 15 % Topical CreamPSNdb6c0c77-0a20-d574-a98f-e6c9998b941f7
724160menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical Cream [Thera-Gesic]SBDdb6c0c77-0a20-d574-a98f-e6c9998b941f7
259203menthol 10 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCDdb6c0c77-0a20-d574-a98f-e6c9998b941f7
259203menthol 1 % / methyl salicylate 15 % Topical CreamSYdb6c0c77-0a20-d574-a98f-e6c9998b941f7
724160Thera-Gesic (menthol 10 MG/ML / methyl salicylate 150 MG/ML) Topical CreamSYdb6c0c77-0a20-d574-a98f-e6c9998b941f7
724160Thera-Gesic Pain Relieving Creme (menthol 1 % / methyl salicylate 15 % ) Topical CreamSYdb6c0c77-0a20-d574-a98f-e6c9998b941f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0320-03001780320031 TUBE in 1 CARTON (0178-0320-03) / 85 g in 1 TUBE1 tube1981-01-012029-02-28NoNoCurrent
0178-0320-05001780320051 TUBE in 1 CARTON (0178-0320-05) > 142 g in 1 TUBE1 tube1981-01-010000-00-00NoNoCurrent
0178-0320-1600178032016454 g in 1 BOTTLE, PLASTIC (0178-0320-16) 454 g1981-01-010000-00-00NoNoCurrent