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 28 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOGUARDLIDOCAINE 4%ViolaCare, Inc.d8b021b6-cf71-4f7e-9d27-92d0982bd34f2026-03-25WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.4dda6ac4-d849-69a6-e063-6394a90a3c542026-03-25WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a33f9a9-1fdc-7cdf-e063-6294a90adca12026-03-25WarningsExact identifier
application number: M017
EjaGuardLIDOCAINEMOLANSPACE INC475f64ef-d636-7e87-e063-6294a90ae32f2026-03-25WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4e53d29c-ed3c-f481-e063-6294a90a31812026-03-25WarningsExact identifier
application number: M017
Topicaine UltraTOPICAINE ULTRAOncora Pharma, LLCe052f718-700a-44e0-8770-65451b812ee12026-03-24WarningsExact identifier
application number: M017
Hot Pap CataplasmaMETHYL SALICYLATE, VANILLYL NONYLAMIDEMasaem Company4dbeda13-b198-0cf0-e063-6294a90a81802026-03-24WarningsExact identifier
application number: M017
Barmicil Anti-itchHYDROCORTISONEOPMX LLC850084c3-1dd4-eb8d-e053-2a91aa0a130b2026-03-24WarningsExact identifier
application number: M017
Jeil Hangbang Paff Soo S CataplasmaGLYCOL SALICYLATE, L-MENTHOLMasaem Company4dd040db-07cf-361a-e063-6394a90a80012026-03-24WarningsExact identifier
application number: M017
Zenol Double ActionMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4da998fc-75a3-583f-e063-6394a90a59c72026-03-23WarningsExact identifier
application number: M017
Ultra Strength Topical Pain Relief CreamCAMPHOR, MENTHOL, METHYL SALICYLATEJ C UDEOZOR & SONS GLOBAL INDUSTRIES LTD4db9ae57-4ab4-8fe4-e063-6394a90a7e512026-03-23WarningsExact identifier
application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ONALIVIO TOTAL ROLL ONEVI LABS4da01338-8739-08a8-e063-6294a90ae1572026-03-22WarningsExact identifier
application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTALALIVIO TOTALEVI LABS4da1c3b8-9af2-6e9f-e063-6394a90a86ae2026-03-22WarningsExact identifier
application number: M017
SORE NO MOREMENTHOL CAMPHORSOMBRA COSMETICS INC.80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd2026-03-20WarningsExact identifier
application number: M017
CVS Health Antiseptic Wound WashLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy53ac017a-eccb-3b24-e054-00144ff88e882026-03-20WarningsExact identifier
application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%ANTI ITCH GELWalgreens3d6e8c62-2fcc-51c2-e063-6394a90a33f72026-03-20WarningsExact identifier
application number: M017
ANIXIKE NumbingMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5c52d7-8e81-b62f-e063-6394a90ad03e2026-03-19WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
application number: M017
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCf7aa9330-c47c-4d2f-b784-11b831d919d62026-03-18WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack99726aa3-3b45-4175-8471-279419af54572026-03-18WarningsExact 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