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 142 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Poli-A	HYDROCORTISONE ACETATE	Sato Pharmaceutical Co., Ltd.	e27a3840-d9de-4bd0-ad75-8a151bd12b83	2023-11-28	Warnings	Exact identifier application number: M017
Sheffield Arthritis and Muscle Pain Relief	CAPSICUM OLEORESIN	Sheffield Pharmaceuticals LLC	724b9870-e86a-4087-ba78-8c944ce3baa6	2023-11-28	Warnings	Exact identifier application number: M017
Dr Sheffield Muscle Rub Cream	MUSCLE RUB CREAM	Sheffield Pharmaceuticals LLC	60d1d826-a53e-42e5-bc30-1b2c2690445b	2023-11-28	Warnings	Exact identifier application number: M017
Thera Plus Cold Therapy Pain Relieving Menthol	MENTHOL	Fourstar Group USA, Inc.	0a462c91-5300-e282-e063-6394a90a4cc2	2023-11-27	Warnings	Exact identifier application number: M017
UtaSpray	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	c641ab11-cd00-4e23-ace7-8178739084f0	2023-11-21	Warnings	Exact identifier application number: M017
Top Medicated Oil	CAMPHOR, MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	b2f0d1e1-7d03-434e-be39-9f980459690c	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief Balm	METHYL SALICYLATE, MENTHOL, CAMPHOR	Big 5 Nutrition LLC	50112419-c934-4d3a-9ea6-9b089f516a6d	2023-11-21	Warnings	Exact identifier application number: M017
BT Pain Relief	MENTHOL, METHYL SALICYLATE	Big 5 Nutrition LLC	91324910-27cf-424f-9e9b-6173f2d7acbf	2023-11-21	Warnings	Exact identifier application number: M017
Dit Da Shui	MENTHOL AND METHYL SALICYLATE	Big 5 Nutrition LLC	5d45cb48-3e88-4d58-81d2-6f88d7a82134	2023-11-20	Warnings	Exact identifier application number: M017
Herbal Balm	METHYL SALICYLATE, MENTHOL AND	Big 5 Nutrition LLC	09b3b86d-3434-428b-b0a8-e8dfd7c0b52a	2023-11-20	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	b505769e-9c46-3cf3-e053-2a95a90a4df9	2023-11-17	Warnings	Exact identifier application number: M017
Hydrocortisone	ANTIPRURITIC (ANTI-ITCH)	BluePoint Laboratories	d6523993-d781-cdbc-e053-2a95a90af191	2023-11-17	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	4d91baf3-9655-4786-93b8-aa0d93fe0bf9	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE LEG CRAMP	MENTHOL	KOBAYASHI Healthcare International, Inc.	7ef03298-6623-4cf4-b21f-74b2ffc11c6e	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	436e8578-b609-4b45-8f84-0d111140fda6	2023-11-16	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL	KOBAYASHI Healthcare International, Inc.	08dcfa78-7332-4f19-90d7-fdd7d446848a	2023-11-16	Warnings	Exact identifier application number: M017
Totally Fun After Sun	LIDOCAINE HCL	MJ Products Association, LLC	965a2a29-914c-4ad0-b25f-5df3c30da393	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	4fdf61d8-a9e0-4cd2-9e3f-0bdedc47a52f	2023-11-15	Warnings	Exact identifier application number: M017
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	KOBAYASHI Healthcare International, Inc.	b44beac3-1d20-434f-9a79-4fab1ac68791	2023-11-15	Warnings	Exact identifier application number: M017
Universal Ice Cold Analgesic	MENTHOL	Universal Distribution Center LLC	79ad55eb-b59d-4bb8-88e3-3b51e10a7f28	2023-11-15	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