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 40 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Itch Relief Gel DIPHENHYDRAMINE HCL Walgreens 487060a7-dff3-4840-b967-ca919f8d0a29 2026-01-15 Warnings Exact identifier application number: M017 Walgreen Itch Relief Gel DIPHENHYDRAMINE HYDROCHLORIDE Walgreens 5aca3297-406f-4165-9895-c58ccffb374f 2026-01-15 Warnings Exact identifier application number: M017 Pain Relieving Patch LIDOCAINE FlexiGo Inc. 4868af2a-c4be-9c68-e063-6394a90a565b 2026-01-15 Warnings Exact identifier application number: M017 Helocaine Cold Sore Fever Blister Treatment TETRACAINE, MINERAL Pagari Life Science Corp. 1b2eae09-5de0-9219-e063-6294a90af046 2026-01-15 Warnings Exact identifier application number: M017 Careland Lidocaine 4 Pain Relieving Gel-Patches LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6ca8382-7ce5-4df9-912e-8a0ac0423116 2026-01-15 Warnings Exact identifier application number: M017 Neuropathy Cream MENTHOL CREAM Owell Naturals Brand, LLC 48739205-627b-41d0-e063-6394a90a3462 2026-01-15 Warnings Exact identifier application number: M017 BLT 1 BENZOCAINE CENTURA PHARMACEUTICALS INC 3eea2171-850b-4045-e054-00144ff8d46c 2026-01-15 Warnings Exact identifier application number: M017 Icy Hot Lidocaine Dry LIDOCAINE, MENTHOL Chattem, Inc. d500a74e-ab93-4919-8665-a89e9d4cad28 2026-01-15 Warnings Exact identifier application number: M017 Cortizone 10 Bug Bite Relief 1% HYDROCORTISONE Chattem, Inc. b21b6c04-8246-4567-98cf-64e8c588e79c 2026-01-15 Warnings Exact identifier application number: M017 Gold Bond Intensive Relief Anti-Itch PRAMOXINE HYDROCHLORIDE, MENTHOL Chattem, Inc. e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f8 2026-01-14 Warnings Exact identifier application number: M017 Cortizone-10 Soothing Aloe Creme HYDROCORTISONE Chattem, Inc. 1a841bf0-9d7b-4566-b442-aa9bcc827846 2026-01-14 Warnings Exact identifier application number: M017 Cortisone 10 Sensitive Skin Creme HYDROCORTISONE Chattem, Inc. b139917c-00bb-4cb3-995d-a6d2f2c295c6 2026-01-14 Warnings Exact identifier application number: M017 Cortizone 10 for Psoriasis HYDROCORTIZONE Chattem, Inc. fad9eedb-95e1-4e1a-91e5-0bfd077e0cf5 2026-01-14 Warnings Exact identifier application number: M017 Pain Relief Roll On TOPICAL ANALGESIC Eagle Labs Inc 2380a400-062a-4a8d-a594-a2e097219044 2026-01-14 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE 4% AvKARE 70aace2f-47b4-e961-e053-2991aa0a6367 2026-01-14 Warnings Exact identifier application number: M017 JUST CBD - ULTRA RELIEF MENTHOL, CAMPHOR Just Brands LLC 485f355a-4458-67b6-e063-6394a90ab2a0 2026-01-14 Warnings Exact identifier application number: M017 Relief Pain Relieving Cream MENTHOL Corganics, LP 85814fff-35f8-447f-b669-87eaf55e9859 2026-01-14 Warnings Exact identifier application number: M017 Mentholatum Soothing Vapor Rub Cherry CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 486269c9-af3a-7856-e063-6294a90a378c 2026-01-14 Warnings Exact identifier application number: M017 Mentholatum Vapor Max CAMPHOR, EUCALYPTUS OIL, MENTHOL The Mentholatum Company 4863606f-f7c8-b4a4-e063-6294a90a1138 2026-01-14 Warnings Exact identifier application number: M017 Hydrocortisone Cream Intensive Healing HYDROCORTISONE CREAM Walgreens 8a3f486c-1353-466d-9ea7-c14559b53bf3 2026-01-14 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