FDA.reportPublic FDA data

MENTHOL, CAMPHOR

Product NDC
72937-103
11-digit product format
729370103
Labeler code
72937
Product ID
72937-103_44250376-aa87-fcb7-e063-6394a90a21c1
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR
Dosage form
CREAM
Route
TOPICAL
Labeler
SUNSET NOVELTIES, INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-10-05
Marketing end
2027-06-19
Substance
MENTHOL; CAMPHOR (NATURAL)
Active strength
10; 3 g/100g; g/100g
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72937-103DDiscontinued by firm2026-10-27
excluded productproduct72937-103DDiscontinued by firm2026-10-27
excluded packagepackage72937-10372937-103-02DDiscontinued by firm2026-10-27
excluded packagepackage72937-10372937-103-16DDiscontinued by firm2026-10-27
excluded packagepackage72937-10372937-103-04DDiscontinued by firm2026-10-27

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct72937-103DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72937-10372937-103-16DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage72937-10372937-103-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
MENTHOL, CAMPHOR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 g/100g
CAMPHOR (NATURAL)3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
N20HL7Q941Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b0edd9d9-951f-d3dd-e053-2995a90a8d5aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72937-103-022022-07-12C16284748780-1d6a99b39-61fe-a426-e053-dadaa90af4c272937-103-02
72937-103-042022-07-12C16284748780-1d6a99b39-c9f3-a426-e053-dadaa90af4c272937-103-04
72937-103-082022-07-12C16284748780-1d6a99b39-e318-a426-e053-dadaa90af4c272937-103-08

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72937-103-08MENTHOL, CAMPHOR226 g in 1 BOTTLECREAM2266

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72937-103MENTHOL, CAMPHOR CREAM [SUNSET NOVELTIES, INC]5Current NDC, Legacy NDC20241122_b0edcf3d-0f58-54d8-e053-2995a90a9c49.zip
72937-103MENTHOL, CAMPHOR CREAM [SUNSET NOVELTIES, INC]5Current NDC, Legacy NDC, 1 package rows20241122_b0edd9d9-951f-d3dd-e053-2995a90a8d5a.zip
72937-103MENTHOL, CAMPHOR CREAM [SUNSET NOVELTIES, INC]4Current NDC, Legacy NDC20241122_b0b63981-1fe3-3eaa-e053-2a95a90ae4e1.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 103 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017
Lidocare Arm, Neck, Leg4% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC59a104ee-7034-99c3-e053-2991aa0a164c2025-01-06WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu Pharmaceutical Co., Inc.4f3a438c-f378-4d2a-a95c-58e56cf1e7972025-01-06WarningsExact identifier
application number: M017
Lidocare 034% LIDOCAINEKingsway Pharmaceuticals dba NFI, LLC416ebf5a-2efb-6d0b-e054-00144ff88e882025-01-06WarningsExact identifier
application number: M017
AVCOO Pain Relief Roll-onMENTHOLADP Health Limitede0bb77b2-45ee-45fa-9659-9c7d99bb20dc2025-01-05WarningsExact identifier
application number: M017
health and beyond BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b6bb3ed-50fb-40c4-acb6-ae3f160315312025-01-05WarningsExact identifier
application number: M017
glo SKIN BEAUTY Remedy GelGLO SKIN BEAUTY REMEDY GELHayden Caleel LLCaa47ff08-07b3-4fd1-bae5-420e4b928f062025-01-05WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72937-103-027293701030256 g in 1 BOTTLE (72937-103-02) 56 g2020-10-020000-00-00NoNoCurrent
72937-103-0472937010304113 g in 1 BOTTLE (72937-103-04) 113 g2020-10-050000-00-00NoNoCurrent
72937-103-0872937010308226 g in 1 BOTTLE (72937-103-08) 226 g2020-10-052027-06-19NoNoCurrent
72937-103-1672937010316452 g in 1 BOTTLE (72937-103-16) 452 g2022-12-050000-00-00NoNoCurrent