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 72 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coralite Muscle and Joint Pain Relief CAPSACIN United Exchange Corp. ba9a3d72-db7a-4dd0-9220-f43c9ed87114 2025-10-21 Warnings Exact identifier application number: M017 Coralite Extra Strength Pain Relief Sleeve Wrist MENTHOL United Exchange Corp. ae314478-b8ab-4e90-bd0a-7a882d5c1b2e 2025-10-21 Warnings Exact identifier application number: M017 Coralite Cold and Hot MENTHOL United Exchange Corp. 85bd7658-e951-7daf-e053-2a91aa0a9f54 2025-10-21 Warnings Exact identifier application number: M017 Family Care Maximum Strength Medicated Anti Itch MENTHOL United Exchange Corp. 430b5753-3087-4cb1-bf54-0eedc3f4b1d5 2025-10-21 Warnings Exact identifier application number: M017 Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. 8e4d46d8-7084-0666-e053-2995a90ad520 2025-10-21 Warnings Exact identifier application number: M017 Coralite Pain Relief CAMPHOR, MENTHOL, METHYL SALICYLATE United Exchange Corp. 69aec845-3d4c-d226-e053-2991aa0afd12 2025-10-21 Warnings Exact identifier application number: M017 WHITE FLOWER ANALGESIC BALM CAMPHOR, MENTHOL AND METHYL SALICYLATE HOE HIN PAK FAH YEOW MANUFACTORY LTD f3e3b8b5-b12b-49ac-9318-b0c358b136e9 2025-10-21 Warnings Exact identifier application number: M017 Mountain Ice Sports Recovery MENTHOL Mountainside Medical Equipment, Inc. 98638529-3c17-436e-901f-c8aea52bdab6 2025-10-20 Warnings Exact identifier application number: M017 Lip Clear Lysine Plus MENTHOL, UNSPECIFIED FORM Quantum, Inc. 21a5b4fb-baed-4766-9820-5c6051c14720 2025-10-20 Warnings Exact identifier application number: M017 Buzz Away Sting Soothe MENTHOL Quantum, Inc. 419e34ea-17b2-ec32-e063-6394a90a603d 2025-10-20 Warnings Exact identifier application number: M017 Family Care Anti-Itch HYDROCORTISONE United Exchange Corp. deb09e89-9794-89a7-e053-2a95a90abdf8 2025-10-20 Warnings Exact identifier application number: M017 Numbing Cream MENTHOL FlexiGo Inc 41571c8f-332b-f423-e063-6394a90a8897 2025-10-20 Warnings Exact identifier application number: M017 Soothing Nerve Therapy MENTHOL Wise Consumer Products 40829d6b-5005-7ec9-e063-6294a90a970e 2025-10-20 Warnings Exact identifier application number: M017 Numbing Cream MENTHOL FlexiGo Inc 4146fd51-b18c-393d-e063-6294a90a4d9a 2025-10-20 Warnings Exact identifier application number: M017 Lidocaine 4% Maximum OTC Strength LIDOCAINE Cardinal Health 107, LLC 975031df-d46d-4098-b1c0-1c0c92b41995 2025-10-20 Warnings Exact identifier application number: M017 Cortizone 10 Intensive Healing HYDROCORTISONE Chattem, Inc. bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c 2025-10-20 Warnings Exact identifier application number: M017 Sting relief pad BENZOCAINE, ALCOHOL Guangdong Comfort Medical Products Co., Ltd. 6e905065-10a9-1ded-e053-2a91aa0a46a1 2025-10-19 Warnings Exact identifier application number: M017 Elgin Pain Relief MENTHOL Eco-Logics, Inc. 375bfe83-c895-3ea7-e054-00144ff88e88 2025-10-18 Warnings Exact identifier application number: M017 Advanced Healing Diabetic Skin Care DIMETHICONE Eco-Logics, Inc. c6704d06-0311-406e-98a7-b8c8881aefd5 2025-10-18 Warnings Exact identifier application number: M017 Elgin Pain Relief MENTHOL Eco-Logics, Inc. 378d1109-6511-1f63-e054-00144ff88e88 2025-10-18 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