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 73 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Cold and Hot MENTHOL CVS Pharmacy a44cec95-822a-40b6-e053-2995a90ae31c 2025-10-17 Warnings Exact identifier application number: M017 Sombra Max SOMBRA MAX Sombra Cosmetics Inc. 41623a46-e6e7-907e-e063-6394a90afc4c 2025-10-17 Warnings Exact identifier application number: M017 POMADA DRAGON PAIN RELIEVING CAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE TELEVISA CONSUMER PRODUCTS USA c283291d-feaa-4f89-8fde-9e3957ea8b9f 2025-10-17 Warnings Exact identifier application number: M017 Ear Pain MD LIDOCAINE HYDROCHLORIDE Eosera Inc 78c4418f-7f0f-447f-a94f-d4c89a081af1 2025-10-17 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 414217c1-ff3a-b556-e063-6394a90aa5db 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41422d04-160b-51b2-e063-6294a90ab2b2 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 41427275-4c35-bbdf-e063-6294a90a14cf 2025-10-16 Warnings Exact identifier application number: M017 Dollar General Menthol Pain Relief Gel Rollon MENTHOL Dolgencorp, LLC 3a9b99e2-36b8-5dcf-e063-6394a90a382d 2025-10-16 Warnings Exact identifier application number: M017 Quality Choice HYDROCORTISONE Chain Drug Marketing Association, Inc. 24c3eb99-92ac-658c-e063-6394a90ab51f 2025-10-16 Warnings Exact identifier application number: M017 DentiCalm TOPICAL ANALGESIC NFUSE LLC 414e6f6f-06bb-b470-e063-6294a90af390 2025-10-16 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE TRANSDERMAL PATCHES Shenzhen Paxi Trading Co., Ltd. 413008cd-d239-1453-e063-6394a90a74f2 2025-10-15 Warnings Exact identifier application number: M017 PERFORM LEO EXTENSIVE PAIN RELIEF LIDOCAINE, MENTHOL PERFORM LEO LLC f993ed5f-7dbb-4e3e-addf-f65b12f5cc48 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Lower Leg Sleeve CAPSAICIN Nufabrx LLC b8e3e528-b7cd-e4b7-e053-2995a90a4029 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Ankle Sleeve CAPSAICIN Nufabrx LLC 013d60c7-a613-7cdf-e063-6294a90ad584 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Calf Sleeve CAPSAICIN Nufabrx LLC bd9459c4-5596-746f-e053-2995a90a5400 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Arm Sleeve CAPSAICIN Nufabrx LLC a7993eaf-6488-a818-e053-2995a90a7ea6 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Back Wrap CAPSAICIN Nufabrx LLC e4f85ac8-57cb-46eb-e053-2995a90a9b1c 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Medicine Infused Socks CAPSAICIN Nufabrx LLC 013cb66f-8695-b69f-e063-6294a90a699c 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Neck Wrap CAPSAICIN Nufabrx LLC e10b420c-500d-5738-e053-2a95a90a008f 2025-10-15 Warnings Exact identifier application number: M017 Nufabrx Knee Sleeve CAPSAICIN Nufabrx LLC a5f455d4-5fc5-d516-e053-2a95a90a921e 2025-10-15 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