OsmoFlex

Product NDC: 67676-101
Requested package NDC: 67676-101-01
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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
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 92 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Numbing Cream	LIDOCAINE	100 KARMA INC	359884d6-188a-e503-e063-6294a90acab4	2025-05-20	Warnings	Exact identifier application number: M017
AY BENDITO - THERMOACTIVE	CAMPHOR, MENTHOL	AY BENDITO - THERMOACTIVE LOTION	835abc66-680f-be06-e053-2a91aa0a309e	2025-05-19	Warnings	Exact identifier application number: M017
Numbing Cream	LIDOCAINE	100 KARMA INC	35884644-d017-eda3-e063-6394a90a1f6c	2025-05-19	Warnings	Exact identifier application number: M017
QUIT SMOKING Proven Patches	NICOTINE	Jiashen International Trade Limited	35570155-c769-dc4c-e063-6394a90a019d	2025-05-17	Warnings	Exact identifier application number: M017
VBBV Tattoo Numbing	LIDOCAINE	Jiashen International Trade Limited	3557859e-f8b3-1049-e063-6394a90ad737	2025-05-17	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	35415851-beba-5bb4-e063-6294a90a35c0	2025-05-16	Warnings	Exact identifier application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	352798e1-1e09-3d47-e063-6394a90ad404	2025-05-15	Warnings	Exact identifier application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	35285d62-c660-a056-e063-6294a90aabc8	2025-05-15	Warnings	Exact identifier application number: M017
SionBiotext Hydrocortisone	HYDROCORTISONE ACETATE 1%	Sion Biotext Medical Ltd	35073eae-26fe-2bb5-e063-6294a90ab56a	2025-05-13	Warnings	Exact identifier application number: M017
Bliss Republic Lidocaine Numbing Cream	LIDOCAINE NUMBING CREAM	Sargass Group Limited Liability Company	3508ae14-d9c9-3c85-e063-6294a90a0098	2025-05-13	Warnings	Exact identifier application number: M017
SORE NO MORE WARM THERAPY	MENTHOL AND CAMPHOR	SOMBRA COSMETICS INC.	cd86b56e-9b4c-4aca-9740-c8793cb12055	2025-05-12	Warnings	Exact identifier application number: M017
SORE NO MORE COOL THERAPY	MENTHOL	SOMBRA COSMETICS INC.	9aa1f0ac-3baf-4e45-9e3a-c28a99b22909	2025-05-12	Warnings	Exact identifier application number: M017
Calm and Correct Serum with Lidocaine	LIDOCAINE 3 PERCENT	Renu Laboratories, LLC	ddcf1c2e-2f67-44d7-e053-2a95a90a812b	2025-05-09	Warnings	Exact identifier application number: M017
Mqupin Knee Patch	KNEE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	09772e4b-8193-3771-e063-6394a90a9516	2025-05-08	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	d57a59fb-c8f2-f73b-e053-2995a90a4cdb	2025-05-08	Warnings	Exact identifier application number: M017
Hydrocortisone Cream	HYDROCORTISONE	Trifecta Pharmaceuticals USA	4c96ec41-841c-322b-e054-00144ff8d46c	2025-05-08	Warnings	Exact identifier application number: M017
GNP Extra Strength Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Amerisource Bergen	34a66224-ef3c-e36e-e063-6394a90ac99d	2025-05-08	Warnings	Exact identifier application number: M017
Good Neighbor Muscle Rub Cream	CAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,	Amerisource Bergen	34924bb9-e3e8-70e6-e063-6294a90aaa8c	2025-05-07	Warnings	Exact identifier application number: M017
DermaRad Relief Post Radiation Calming	LIDOCAINE 3 PERCENT	Renu Laboratories, LLC	e5d64929-fb9c-7ebc-e053-2995a90a9318	2025-05-07	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	InterMed Laboratories Private Limited	33ee0235-5a6e-0ea1-e063-6394a90a89a5	2025-05-06	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
436147	menthol 1.3 % Topical Cream	PSN	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	7
1050947	Osmoflex 1.3 % Topical Cream	PSN	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	7
1050947	menthol 13 MG/ML Topical Cream [Osmoflex]	SBD	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	7
436147	menthol 13 MG/ML Topical Cream	SCD	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	7
436147	menthol 1.3 % Topical Cream	SY	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	7
1050947	Osmoflex 1.3 % Topical Cream	SY	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	7
1050947	Osmoflex 13 MG/ML Topical Cream	SY	479147c0-4cf4-4d7a-8b8e-1a0de49ed73e	7

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