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 130 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SANTO REMEDIO Alivio Pain Relieving Lavender Scent LIDOCAINE HYDROCHLORIDE, MENTHOL SANTO REMEDIO LLC ab53c7f2-a768-4f36-89d6-e128a1a940c2 2024-08-05 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT CVS Health ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3 2024-08-02 Warnings Exact identifier application number: M017 Anti-Itch Vulva Cream 1 Hydrocortisone Acetate HYDROCORTISONE ACETATE The Honey Pot Company LLC 6f32b536-6ebf-49a8-abb6-2a1daae2f6d7 2024-08-01 Warnings Exact identifier application number: M017 Anti Itch Soothing 1 Pramoxine Hydrochloride PRAMOXINE HYDROCHLORIDE The Honey Pot Company LLC 8bfeea34-25d5-4721-a17f-d9f1d0084cc3 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Arthritis Achy Foot and Muscle METHYL SALICYLATE The Avon Company 1f440f60-cfc4-511e-e063-6294a90a87db 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Maximum Strength Cracked Heel BENZALKONIUM CHLORIDE, LIDOCAINE The Avon Company 1f45752e-4a55-431e-e063-6294a90aa57a 2024-08-01 Warnings Exact identifier application number: M017 Relief MENTHOL La Mend, Inc. 1f92de3a-7180-5884-e063-6294a90aebf5 2024-08-01 Warnings Exact identifier application number: M017 Meijer Medicated Foot Powder MENTHOL Meijer Distribution 07ec6c20-73c4-e5e4-e063-6294a90a7e55 2024-07-29 Warnings Exact identifier application number: M017 Ralli Rapid Pain Relief MENTHOL Troy Manufacturing, Inc. e05ec3b7-e9ab-4eaa-8518-86304336697c 2024-07-29 Warnings Exact identifier application number: M017 Walgreens Roll-On CAPSAISIN 0.1% Walgreens Co 1e65bf31-15c7-5e6a-e063-6394a90ac956 2024-07-29 Warnings Exact identifier application number: M017 Camphotrex CAMPHOR, MENTHOL PureTek Corporation 3b6c6eef-e92d-497d-afe8-82356637c2b8 2024-07-26 Warnings Exact identifier application number: M017 Camphotrol CAMPHOR, MENTHOL PureTek Corporation ccac9f37-a374-4765-e053-2a95a90ad2f7 2024-07-26 Warnings Exact identifier application number: M017 Real Time Pain Relief Foot MENTHOL Real Time Products Inc. 29c8e06d-9b29-44f9-ac21-9160d06475cb 2024-07-24 Warnings Exact identifier application number: M017 Capsaicin 0.075 Percent CAPSAICIN Alexso, Inc 33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd 2024-07-22 Warnings Exact identifier application number: M017 TIDL Pain Relief CRYO Therapy Limited Edition PAIN RELIEF CRYO THERAPY LIMITED EDITION Shenzhen Sam Technology Co., Ltd. 1d966b67-fd9c-eab6-e063-6294a90aa75e 2024-07-19 Warnings Exact identifier application number: M017 Fruit of the Earth Aloe Vera Cool Blue LIDOCAINE HYDROCHLORIDE Fruit of the Earth, Inc. 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79 2024-07-19 Warnings Exact identifier application number: M017 Ultra Balm MENTHOL AND METHYL SALICYLATE Ling Nam Medicine Factory (H.K.) Ltd. de997baf-aa04-474e-b912-3fc67e720d0b 2024-07-19 Warnings Exact identifier application number: M017 Ling Nam Hak Kwai Oil TURPENTINE OIL Ling Nam Medicine Factory (H.K.) Ltd. 3f16cce3-366f-41f3-8829-6de4082a8c19 2024-07-19 Warnings Exact identifier application number: M017 Koong Yick Hak Kwai Oil TURPENTINE OIL Ling Nam Medicine Factory (H.K.) Ltd. bc33e185-3b42-98b5-e053-2995a90a6308 2024-07-18 Warnings Exact identifier application number: M017 Koong Yick Hung Fa METHYL SALICYLATE Ling Nam Medicine Factory (H.K.) Ltd. 9c8a121d-6da2-4435-a2d7-a0b71d10740d 2024-07-18 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