FDA.reportPublic FDA data

ChapStick Classic Medicated

Product NDC
83711-809
Requested package NDC
83711-809-47
11-digit product format
837110809
Labeler code
83711
Product ID
83711-809_4e4ef8f1-df6f-a07c-e063-6394a90a4249
Type
HUMAN OTC DRUG
Nonproprietary name
External Analgesic and Skin Protectant Lip Balm
Dosage form
STICK
Route
TOPICAL
Labeler
Suave Brands Co., LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-31
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
1.6; .6 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
ChapStick Classic Medicated
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)1.6 g/100g
MENTHOL.6 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42798a6c-2d7e-80f6-e063-6294a90a105fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83711-809-47ChapStick Classic Medicated4 g in 1 APPLICATORSTICK47
83711-809-50ChapStick Classic Medicated4 g in 1 APPLICATORSTICK47
83711-809-51ChapStick Classic Medicated4 g in 1 APPLICATORSTICK47

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 82 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Active Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3a9f9ca0-3d8a-796a-e063-6394a90a790c2025-08-01WarningsExact identifier
application number: M017
Active Recovery Pain Relief StickCAMPHOR, MENTHOLCharlottes Web, Inc.3aa037c6-6109-b52e-e063-6394a90a215b2025-08-01WarningsExact identifier
application number: M017
PM Recovery Pain ReliefCAMPHOR, MENTHOLCharlotte's Web, Inc.3aa08859-809d-de8c-e063-6394a90a8e252025-08-01WarningsExact identifier
application number: M017
Wish ultra winter iceMENTHOLLJ Pharmab4c5487c-1314-4d63-96df-077e72e7ee952025-08-01WarningsExact identifier
application number: M017
Rugged Fit Pain Relief Roll OnMENTHOL, METHYL SALICYLATESYSTEM4BOOK LLC39d68734-981c-14d7-e063-6294a90a49192025-08-01WarningsExact identifier
application number: M017
ICY FREEZEMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.28fdb049-b297-4358-9447-7d69ba8797022025-08-01WarningsExact identifier
application number: M017
Cortizone 10 CoolingHYDROCORTISONEChattem, Inc.14d9fce2-9f54-4204-83cb-161de8a303f02025-08-01WarningsExact identifier
application number: M017
Bravado Labs NumbingLIDOCAINE HCLProdigy Media Inc8c43f5b5-b911-4a7a-b2d1-56a09c54b0012025-07-30WarningsExact identifier
application number: M017
Chimera GUARDLIDOCAINE PAIN RELIEFING PATCHHangzhou Rongna Health Technology Co., Ltd.3721c984-1993-6265-e063-6394a90af23f2025-07-29WarningsExact identifier
application number: M017
Chimera GUARDLIDOCAINE PAIN RELIEFING PATCHHangzhou Rongna Health Technology Co., Ltd.3758d625-010f-7441-e063-6394a90a066d2025-07-29WarningsExact identifier
application number: M017
Cold Therapy Roll onCOLD THERAPY ROLL ONAllegiant Health36463acb-7c28-416f-a45f-a93f0be5692b2025-07-29WarningsExact identifier
application number: M017
ProCure Anti ItchCAMPHOR 0.5%Twin Med LLC3afe387c-ef42-215d-e063-6394a90a41b52025-07-28WarningsExact identifier
application number: M017
lidocaine pain relief patchesLIDOCAINEChangsha Maocheng Trading Co., Ltd3afeead3-4f5c-4711-e063-6294a90aacca2025-07-28WarningsExact identifier
application number: M017
SYNC ICESYNC RELIEF ICEiON Pharma, LLC38ce98ce-a7bf-8041-e063-6394a90ae7302025-07-28WarningsExact identifier
application number: M017
SYNC PROSYNC RELIEF PRO CREAMiON Pharma, LLC3a3e91d6-732b-dca9-e063-6394a90a06d42025-07-28WarningsExact identifier
application number: M017
Careland Pain ReliefMETHYL SALICYLATE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.83f36771-1033-4fd0-a0e6-82c1dcfedeee2025-07-28WarningsExact identifier
application number: M017
Rite Aid anti-itchHYDROCORTISONERite Aid Corporation2a232dd1-9071-4c55-a7f7-19d8404b99a62025-07-28WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONERITE AID CORPORATION05598255-3e7a-46a5-ae7e-dcfcb616d59d2025-07-28WarningsExact identifier
application number: M017
Inked InspiredLIDOCAINE HCLProdigy Media Inc54fb2860-7e63-4598-953a-170226e613e92025-07-28WarningsExact identifier
application number: M017
Ujhay Hydrocortisone Ointment.UJHAY HYDROCORTISONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.3af59276-8e6a-0603-e063-6394a90a1f9b2025-07-27WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83711-809-47837110809474 g in 1 APPLICATOR (83711-809-47) 4 g2025-10-31NoNoCurrent