Home NDC 67676-101 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 Ingredient Strength MENTHOL 1.3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 436147 Internal RxNorm lookup 1050947 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67676-101-01 OsmoFlex 113.4 g in 1 TUBE CREAM 113.4 7 67676-101-03 OsmoFlex 964.3 g in 1 BOTTLE CREAM 964.3 7 67676-101-04 OsmoFlex 453.6 g in 1 BOTTLE CREAM 453.6 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MENTHOL ACTIVE INGREDIENT L7T10EIP3A OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 ACRYLAMIDE INACTIVE INGREDIENT 20R035KLCI OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 CAPRYLYL GLYCOL INACTIVE INGREDIENT 00YIU5438U OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 CHONDROITIN SULFATE (BOVINE) INACTIVE INGREDIENT 6IC1M3OG5Z OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 DIMETHYL SULFONE INACTIVE INGREDIENT 9H4PO4Z4FT OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 GLUCOSAMINE SULFATE INACTIVE INGREDIENT 1FW7WLR731 OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 GLYCERYL STEARATE CITRATE INACTIVE INGREDIENT WH8T92A065 OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 HYDROGENATED SOYBEAN LECITHIN INACTIVE INGREDIENT H1109Z9J4N OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 ISOHEXADECANE INACTIVE INGREDIENT 918X1OUF1E OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 MAGNESIUM SULFATE HEPTAHYDRATE INACTIVE INGREDIENT SK47B8698T OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 POLYISOBUTYLENE (1200000 MW) INACTIVE INGREDIENT FLT10CH37X OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 POLYOXYL 100 STEARATE INACTIVE INGREDIENT YD01N1999R OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 TRICAPRYLIN INACTIVE INGREDIENT 6P92858988 OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67676-101 OSMOFLEX (MENTHOL) CREAM [SARATI INTERNATIONAL, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20231102_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 12 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Natures Willow Balm Roll On Pain Relief MENTHOL WB Ventures LLC 3b1834e6-75cd-5380-e063-6294a90ad1d5 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Balm Itch Relief Cream MENTHOL WB Ventures LLC 0ce31b5d-4401-460c-e063-6394a90ab558 2026-07-08 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc. 560a4abf-31dd-333f-e063-6294a90a3505 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Balm MENTHOL WB VENTURES LLC b9f50c43-b0d5-39a8-e053-2995a90a04f1 2026-07-08 Warnings Exact identifier application number: M017 Natures Willow Bug Bite Balm MENTHOL WB Ventures LLC b9fab18f-32c7-d5bd-e053-2995a90a6d0f 2026-07-08 Warnings Exact identifier application number: M017 Salonpas pain relieving hot CAPSAICIN, MENTHOL Hisamitsu Pharmaceutical Co., Inc. d2aa8820-a947-404b-b617-e692fbd16502 2026-07-07 Warnings Exact identifier application number: M017 Quali Yi Tiao Gen Pain Patch CAPSAICIN PATCH Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory 33154a9b-f6d0-4e95-b4cb-6b938f5dcf4d 2026-07-07 Warnings Exact identifier application number: M017 MUYOHON Numbing Cream NUMBING CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 55caf0a5-f062-a6c3-e063-6294a90ae073 2026-07-04 Warnings Exact identifier application number: M017 Targeted Warming Capsaicin Patch CAPSAICIN Army & Air Force Exchange Service 55b539f8-38c4-594e-e063-6394a90afbaa 2026-07-03 Warnings Exact identifier application number: M017 TopCare Health Pain Relief LIDOCAINE HYDROCHLORIDE Topco Associates LLC 485b0671-da09-19d7-e063-6294a90aca5d 2026-07-03 Warnings Exact identifier application number: M017 Mineral Ice Methol Pain Relief MENTHOL 10.5 % Sunflora Inc 6ddd9e97-f717-4d5a-9658-26449a3cc831 2026-07-02 Warnings Exact identifier application number: M017 Burn Relief LIDOCAINE AmerisourceBergen Drug Corporation 7d898e33-ded7-c9b9-e053-2a91aa0adf7c 2026-07-01 Warnings Exact identifier application number: M017 Desert Harvest Releveum with Lidocaine LIDOCAINE HYDROCHLORIDE Desert Harvest, Inc 9ad514ab-a6bd-4564-8ba3-0149032ebf36 2026-07-01 Warnings Exact identifier application number: M017 CVS No Mess Cortisone HYDROCORTISONE Natural Essentials, Inc. 558c94ec-95f1-eb98-e063-6394a90a1e72 2026-07-01 Warnings Exact identifier application number: M017 MUSCLE EASE MENTHOL CAMPHOR SOMBRA COSMETICS INC. 03fff4bf-04ed-49a6-b40f-4d98c2b42f69 2026-07-01 Warnings Exact identifier application number: M017 OrthoNesic Pain Relieving Gel MENTHOL, CAMPHOR Blaine Labs Inc. 122f60c2-f8df-4625-8bb8-a2244a261b5d 2026-07-01 Warnings Exact identifier application number: M017 Desert Harvest RELEVEUM LIDOCAINE Desert Harvest Inc. 5d9010ec-d482-44ff-ba27-3bfec5a241c6 2026-06-30 Warnings Exact identifier application number: M017 Promescent LIDICAINE Absorption 5b508238-3be7-4b0d-bf35-51de79f58f55 2026-06-30 Warnings Exact identifier application number: M017 Lidovyx LIDOCAINE 4% V2 Pharma LLC 4465eb60-a617-4608-9504-8b3b4c64f49e 2026-06-30 Warnings Exact identifier application number: M017 Dr.Johnes Lidocaine 4% Topical Analgesic Cream LIDOCAINE HCL,MENTHOL Dr.Johnes LLC 6144708d-4b0f-4f0d-88e3-6925ba2d004d 2026-06-29 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67676-101-01 67676010101 113.4 g in 1 TUBE (67676-101-01) 113.4 g 2016-05-16 0000-00-00 No No Current 67676-101-03 67676010103 964.3 g in 1 BOTTLE (67676-101-03) 964.3 g 2016-05-16 0000-00-00 No No Current 67676-101-04 67676010104 453.6 g in 1 BOTTLE (67676-101-04) 453.6 g 2016-05-16 0000-00-00 No No Current