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.

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 119 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
First Aid Only Burn	LIDOCAINE HYDROCHLORIDE	Acme United Corporation	9af39fcd-0a57-26d0-e053-2a95a90a99a0	2024-11-17	Warnings	Exact identifier application number: M017
First Aid Only First Aid/Burn	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Acme United Corporation	caa67a05-bdbd-c380-e053-2995a90a0bf1	2024-11-17	Warnings	Exact identifier application number: M017
Meijer Pain Lidocaine Plus Relieving Analgesic	BENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	b7385140-3f63-4cbc-b557-de1d29d1ea36	2024-11-15	Warnings	Exact identifier application number: M017
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	c6b9c4e1-bab8-490d-8c00-c43377ad0857	2024-11-15	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Walgreen Company	1a9b8b4c-3e15-49e6-af91-76ed0dc0829e	2024-11-15	Warnings	Exact identifier application number: M017
Lidocaine	LIDOCAINE	Patrin Pharma Inc.	91eedf9d-53b8-49d5-af59-25019606a0b2	2024-11-15	Warnings	Exact identifier application number: M017
equaline anti itch maximum strength	HYDROCORTISONE	United Natural Foods, Inc. dba UNFI	d1ac686e-62f2-4177-8abc-8c7ca578de1a	2024-11-15	Warnings	Exact identifier application number: M017
Meijer Pain Relieving Max Strength with Lavender Essential Oil Analgesic	LIDOCAINE HYDROCHLORIDE	Meijer Distribution, Inc	e688967e-799a-4fc8-a19a-f0012b90e76b	2024-11-15	Warnings	Exact identifier application number: M017
basic care hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	a0d0e82b-03ff-4d43-9be0-0e414ee49970	2024-11-15	Warnings	Exact identifier application number: M017
DG health hydrocortisone	HYDROCORTISONE	Dolgencorp, LLC	40710bae-32bb-47fd-b3dd-31d2c98ee70f	2024-11-15	Warnings	Exact identifier application number: M017
Meijer Ultra Strength Pain Relieving Topical Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Meijer Distribution, Inc	6319b019-8e17-4de1-b4e0-b402288a97d4	2024-11-15	Warnings	Exact identifier application number: M017
Meijer Pain Relieving analgesic	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	9953be94-5768-448f-83de-f5e53a2972cc	2024-11-15	Warnings	Exact identifier application number: M017
careone anti itch	HYDROCORTISONE	American Sales Company	5f7b1435-ebee-4093-847a-79e8d6641404	2024-11-15	Warnings	Exact identifier application number: M017
Tiger Balm	METHYL SALICYLATE AND MENTHOL	Haw Par Healthcare Ltd.	51293a06-5922-4072-ae14-afaba9c1b58e	2024-11-14	Warnings	Exact identifier application number: M017
Tylenol Precise Warming Pain Relieving	LIDOCAINE	Kenvue Brands LLC	0c60b607-ade9-68f2-e063-6394a90a4025	2024-11-13	Warnings	Exact identifier application number: M017
Tylenol Precise Pain Relieving	LIDOCAINE	Kenvue Brands LLC	fc1e0451-8c84-729e-e053-6394a90aaba0	2024-11-13	Warnings	Exact identifier application number: M017
Neosporin Plus Pain Relief First Aid Antibiotic/Pain Relieving	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	23222e54-d793-4d79-980e-550e32a95742	2024-11-13	Warnings	Exact identifier application number: M017
TopCare Pain Relieving Roll-On Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Topco Associates LLC	48589893-ca67-471d-88bc-92014295ab9f	2024-11-13	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	a1c1b878-d58f-41ff-b7a8-477f28c52667	2024-11-12	Warnings	Exact identifier application number: M017
Real Time Pain Relief Maxx Plus Topical Analgesic	MENTHOL	Real Time Products Inc.	fc509a55-594d-4d44-87db-33286e937581	2024-11-12	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
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