FDA.reportPublic FDA data

OsmoFlex

Product NDC
67676-101
11-digit product format
676760101
Labeler code
67676
Product ID
67676-101_08b4632c-2421-6046-e063-6294a90a1527
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
Sarati International, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-05-16
Substance
MENTHOL
Active strength
1.3 g/100g
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
OsmoFlex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
436147Internal RxNorm lookup
1050947Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
479147c0-4cf4-4d7a-8b8e-1a0de49ed73eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67676-101-01OsmoFlex113.4 g in 1 TUBECREAM113.47
67676-101-03OsmoFlex964.3 g in 1 BOTTLECREAM964.37
67676-101-04OsmoFlex453.6 g in 1 BOTTLECREAM453.67

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3AOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
ACRYLAMIDEINACTIVE INGREDIENT20R035KLCIOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
CHONDROITIN SULFATE (BOVINE)INACTIVE INGREDIENT6IC1M3OG5ZOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
GLUCOSAMINE SULFATEINACTIVE INGREDIENT1FW7WLR731OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
GLYCERYL STEARATE CITRATEINACTIVE INGREDIENTWH8T92A065OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1EOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
MAGNESIUM SULFATE HEPTAHYDRATEINACTIVE INGREDIENTSK47B8698TOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
POLYISOBUTYLENE (1200000 MW)INACTIVE INGREDIENTFLT10CH37XOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999ROSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
TRICAPRYLININACTIVE INGREDIENT6P92858988OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67676-101OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.]7Current NDC, Legacy NDC, 3 package rows20231102_479147c0-4cf4-4d7a-8b8e-1a0de49ed73e.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 87 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsExact identifier
application number: M017
Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETARGET Corporation6fba5890-f48f-4302-a8ac-5087a6e03bd52025-07-11WarningsExact identifier
application number: M017
TopCare Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC55dc4025-f07f-41b2-8b18-6a11ee04b5cc2025-07-11WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC309d9be0-e367-429a-a1fa-ab7855477c8a2025-07-10WarningsExact identifier
application number: M017
Bengay Vanishing ScentMENTHOL, UNSPECIFIED FORMKenvue Brands LLC6cc3294b-3b0f-44d0-af71-61db1022d2692025-07-10WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLQuality Choicece544a7c-8dc6-4e63-b499-d8a4e0ec48c32025-07-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsExact identifier
application number: M017
CVS CortisoneHYDROCORTISONECVS Pharmacy87631be8-94b8-4718-858d-d2f30e636cce2025-07-10WarningsExact identifier
application number: M017
TopCare Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETopco Associates LLCc40e8e1d-d6d7-4880-99d3-011b97a5e4f32025-07-10WarningsExact identifier
application number: M017
Live Better Hydrocortisone with AloeHYDROCORTISONEThe Great Atlantic & Pacific Tea Company044e6ee2-98a6-4802-b33d-78b8551356c42025-07-10WarningsExact identifier
application number: M017
Rocainol TOPICAL ANALGESICMETHYL SALICYLATE, MENTHOLCompania Internacional de Comercio, S.A.P.I de C.V.827ec7b2-3d87-47e0-a47a-966b25732c322025-07-10WarningsExact identifier
application number: M017
NumbR-XLIDOCAINE HCLProdigy Media Inc16329ab6-4a33-4c38-85e0-5aad9c75d61d2025-07-10WarningsExact identifier
application number: M017
Dr LidoLIDOCAINE HCLProdigy Media Incda0938f0-00e7-4502-8721-d64c71f594fc2025-07-10WarningsExact identifier
application number: M017
Pain Relief PatchCAMPHOR, METHYL SALICYLATE, MENTHOLCDMA, Inc.da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b2025-07-09WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEAmerisourceBergenf36acdb8-a526-4bb7-a557-e1dcbbc1cf452025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone with AloeHYDROCORTISONEAmerisourceBergen0c544792-63d9-400c-9888-207c44fdc75e2025-07-08WarningsExact identifier
application number: M017
Good Neighbor Pharmacy HydrocortisoneHYDROCORTISONEAmerisourceBergen58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf2025-07-08WarningsExact identifier
application number: M017
Publix HydroHYDROCORTISONEPublix Super Markets Inc29296b0f-0eed-4bb9-8727-c25c2bcf9fd62025-07-08WarningsExact identifier
application number: M017
Publix hydro plusHYDROCORTISONEPublix Super Markets Inca00d82c1-6b09-424a-be78-2603eee3fb9d2025-07-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
436147menthol 1.3 % Topical CreamPSN479147c0-4cf4-4d7a-8b8e-1a0de49ed73e7
1050947Osmoflex 1.3 % Topical CreamPSN479147c0-4cf4-4d7a-8b8e-1a0de49ed73e7
1050947menthol 13 MG/ML Topical Cream [Osmoflex]SBD479147c0-4cf4-4d7a-8b8e-1a0de49ed73e7
436147menthol 13 MG/ML Topical CreamSCD479147c0-4cf4-4d7a-8b8e-1a0de49ed73e7
436147menthol 1.3 % Topical CreamSY479147c0-4cf4-4d7a-8b8e-1a0de49ed73e7
1050947Osmoflex 1.3 % Topical CreamSY479147c0-4cf4-4d7a-8b8e-1a0de49ed73e7
1050947Osmoflex 13 MG/ML Topical CreamSY479147c0-4cf4-4d7a-8b8e-1a0de49ed73e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67676-101-0167676010101113.4 g in 1 TUBE (67676-101-01) 113.4 g2016-05-160000-00-00NoNoCurrent
67676-101-0367676010103964.3 g in 1 BOTTLE (67676-101-03) 964.3 g2016-05-160000-00-00NoNoCurrent
67676-101-0467676010104453.6 g in 1 BOTTLE (67676-101-04) 453.6 g2016-05-160000-00-00NoNoCurrent