FDA.reportPublic FDA data

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
MENTHOL; METHYL SALICYLATE
Active strength
10; 150 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Theragesic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 mg/g
METHYL SALICYLATE150 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A, LAV5U5022Y
Rxcui259203, 724160

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0178-0320-032023-08-31C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-052023-08-31C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-162023-08-31C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-032022-01-28C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-052022-01-28C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-GESIC ® Creme
0178-0320-162022-01-28C16284748780-1d6a99b39-3617-a426-e053-dadaa90af4c2THERA-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 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

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 tube1981-01-010000-00-00NoNoCurrent
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