FDA.reportPublic FDA data

MENTHOL, CAMPHOR

Product NDC
72937-006
11-digit product format
729370006
Labeler code
72937
Product ID
72937-006_44130c5e-f752-2432-e063-6394a90aa5ec
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
SUNSET NOVELTIES, INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-09-22
Marketing end
2027-01-03
Substance
MENTHOL; CAMPHOR, (-)-
Active strength
6; 2 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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72937-006DDiscontinued by firm2026-10-20
excluded productproduct72937-006DDiscontinued by firm2026-10-20
excluded packagepackage72937-00672937-006-02DDiscontinued by firm2026-10-20
excluded packagepackage72937-00672937-006-04DDiscontinued by firm2026-10-20
excluded packagepackage72937-00672937-006-16DDiscontinued by firm2026-10-20
excluded packagepackage72937-00672937-006-40DDiscontinued by firm2026-10-20
excluded packagepackage72937-00672937-006-80DDiscontinued by firm2026-10-20
excluded packagepackage72937-00672937-006-42DDiscontinued by firm2026-10-20

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 · 6 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage72937-006-04
excluded packagepackage72937-006-80
excluded packagepackage72937-006-40
excluded packagepackage72937-006-16
excluded packagepackage72937-006-02

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
MENTHOL6 g/100g
CAMPHOR, (-)-2 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
213N3S8275Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f03090fa-f7e6-f53a-e053-2a95a90aa819Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72937-006-02MENTHOL, CAMPHOR59 g in 1 BOTTLEGEL596
72937-006-04MENTHOL, CAMPHOR118 g in 1 BOTTLEGEL1186
72937-006-08MENTHOL, CAMPHOR236 g in 1 BOTTLEGEL2366
72937-006-16MENTHOL, CAMPHOR472 g in 1 BOTTLEGEL4726

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72937-006MENTHOL, CAMPHOR GEL [SUNSET NOVELTIES, INC]5Current NDC, Legacy NDC, 4 package rows20241121_f03090fa-f7e6-f53a-e053-2a95a90aa819.zip
72937-006MENTHOL, CAMPHOR GEL [SUNSET NOVELTIES, INC]3Current NDC, Legacy NDC20240207_fc9d43a3-d59d-0ee5-e053-6294a90a4539.zip
72937-006MENTHOL, CAMPHOR GEL [SUNSET NOVELTIES, INC]1Current NDC, Legacy NDC20240209_10d0a0ac-aaad-7750-e063-6294a90a30fd.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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
application number: M017
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
application number: M017
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
application number: M017
DO ME DELAYLIDOCAINE HCLProdigy Media Inc5255ee85-6f29-0776-e063-6394a90a525b2026-05-21WarningsExact identifier
application number: M017
Australian Dream Back PainHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.5256a63e-e6da-84c1-e063-6294a90a8dff2026-05-21WarningsExact identifier
application number: M017
SINSIN HANBANG FLEXCAMPHOR, MENTHOLSinsin Pharmaceutical co., ltd.525c5d18-bfc1-3002-e063-6394a90a5b1d2026-05-21WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.6c9a076e-6316-427b-9ce6-c8fe2d3888372026-05-21WarningsExact identifier
application number: M017
Medi-First Capsaicin CreamCAPSAICINUnifirst First Aid Corporation49eb807b-fa31-3d84-e063-6394a90acfcf2026-05-20WarningsExact identifier
application number: M017
Biofreeze Triple Target Roll-OnCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC5089c088-3026-233a-e063-6394a90a93b62026-05-19WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP522f1521-f9f2-4c26-e063-6394a90a9e052026-05-19WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin Roll onCAPSAICIN 0.1%Easment LLC521212d6-57fd-4a7a-e063-6294a90a2a182026-05-18WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEWALMART INC.15af4557-4baf-c177-e063-6294a90a7a5b2026-05-18WarningsExact identifier
application number: M017
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
application number: M017
Tiger BalmCAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.5066dc10-e4d5-49e9-9a5f-0ac220cfbf282026-05-18WarningsExact identifier
application number: M017
Deep Blue MiniMENTHOLdoTERRA International, LLC51dd58a8-1fd5-9cd7-e063-6394a90a1f722026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72937-006-027293700060259 g in 1 BOTTLE (72937-006-02) 59 g2022-09-080000-00-00NoNoCurrent
72937-006-0472937000604118 g in 1 BOTTLE (72937-006-04) 118 g2022-09-080000-00-00NoNoCurrent
72937-006-0872937000608236 g in 1 BOTTLE (72937-006-08) 236 g2022-09-082027-01-03NoNoCurrent
72937-006-1672937000616472 g in 1 BOTTLE (72937-006-16) 472 g2022-09-080000-00-00NoNoCurrent