FDA.reportPublic FDA data

Pain Relieving

Product NDC
70000-0744
11-digit product format
700000744
Labeler code
70000
Product ID
70000-0744_8e3cc302-5df9-4e7b-83a9-0c33a27b05c0
Type
HUMAN OTC DRUG
Nonproprietary name
Trolamine Salicylate
Dosage form
CREAM
Route
TOPICAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-04
Substance
TROLAMINE SALICYLATE
Active strength
100 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Pain Relieving
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROLAMINE SALICYLATE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H8O4040BHDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313518Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b813262e-57c6-4d2c-8cc0-7a17f6f59343Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0744-1Pain Relieving85 g in 1 TUBECREAM852
70000-0744-1Pain Relieving1 in 1 CARTONCREAM12

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 16 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Ice Extreme Dry StickMENTHOLCarlin Consumer Health LLC4f81be91-92e5-1205-e063-6394a90a6e822026-06-02WarningsExact identifier
application number: M017
Kalaya Extra Strength Pain Relief Gel with ArnicaMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpb6a6237d-b471-4102-b5df-fc389f5f92582026-06-02WarningsExact identifier
application number: M017
Biofreeze UltraflexLIDOCAINEReckitt Benckiser LLC2655974b-a67d-9f07-e063-6294a90a54e82026-06-02WarningsExact identifier
application number: M017
Biofreeze Ultraflex PlusLIDOCAINE, MENTHOLReckitt Benckiser LLC401e1843-e9a6-fda9-e063-6294a90a30732026-06-02WarningsExact identifier
application number: M017
Pain ReliefMENTHOL SPRAYOwell Naturals Brand, LLC534c871c-da35-6135-e063-6294a90aa9f62026-06-02WarningsExact identifier
application number: M017
Charm Tex FLUORIDE GelSODIUM FLUORIDEJiangsu Gold Worldworks Household Chemicals Co., Ltd.09d47bd7-1438-4ef2-85e0-9cd5eb2f763a2026-05-31WarningsExact identifier
application number: M017
Charm Tex FLUORIDESODIUM MONOFLUOROPHOSPHATEJiangsu Gold Worldworks Household Chemicals Co., Ltd.2bddc69a-0c0f-47fc-bc98-90c2ec70dd6f2026-05-31WarningsExact identifier
application number: M017
Sting Relief Prep PadBENZOCAINENINGBO TIANBO FIRST AID PRODUCT CO., LTD.9487d15d-9116-4ff8-a004-ba0835ea091e2026-05-31WarningsExact identifier
application number: M017
Careland Kinesiology Pain Relieving TapeCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.35d24cfc-9d34-4fd7-9312-1673b092a3b92026-05-31WarningsExact identifier
application number: M017
Walgreens Scalp Itch ReliefHYDROCORTISONEWalgreens34952272-1f9e-c642-e063-6394a90ae2bd2026-05-29WarningsExact identifier
application number: M017
Aspercreme with Lidocaine No-Mess ApplicatorLIDOCAINE HYDROCHLORIDEChattem, Inc.8092cde7-28d0-4755-b5c0-5765934e572f2026-05-29WarningsExact identifier
application number: M017
Belladona and ArnicaMENTHOLDannso Corp./d.b.a. Essential Productsfc4e63e4-cebc-49ff-8900-7238261d0fe02026-05-28WarningsExact identifier
application number: M017
Insect Sting ReliefBENZOCAINE, ALCOHOLHubei Fanjian Medical Product Co.,Ltdf30401c1-961e-44dd-e053-2a95a90a69d62026-05-28WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a054949-0889-7182-e063-6394a90aff5e2026-05-28WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDECVS Pharmacy960bfe55-87f6-3e51-e053-2995a90a867d2026-05-27WarningsExact identifier
application number: M017
MyDerm Medical 5 Lidocaine Numbing Roll-OnLIDOCAINEInspec Solutions1d466be1-a780-462f-8dd4-87478da096aa2026-05-27WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLC.d427d623-c2fd-7d6b-e053-2995a90abdc32026-05-27WarningsExact identifier
application number: M017
Caldyphen ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEAmerisource Bergend8802e56-649e-4494-86ee-7ca8841cc28b2026-05-27WarningsExact identifier
application number: M017
Equate Itch Relief GelITCH RELIEF GELWalmart, Inc7d7bb750-017e-c60e-e053-2991aa0ad6712026-05-26WarningsExact identifier
application number: M017
MyDerm Bite and StingBENZOCAINEMedline Industriesbf45c4dd-5814-4602-b96b-f82a449487632026-05-26WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313518trolamine salicylate 10 % Topical CreamPSNb813262e-57c6-4d2c-8cc0-7a17f6f593432
313518trolamine salicylate 100 MG/ML Topical CreamSCDb813262e-57c6-4d2c-8cc0-7a17f6f593432
313518trolamine salicylate 10 % Topical CreamSYb813262e-57c6-4d2c-8cc0-7a17f6f593432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70000-0744-1700000744011 TUBE in 1 CARTON (70000-0744-1) / 85 g in 1 TUBE1 tube2025-12-04NoNoCurrent