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 26 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr Sabharwals	LIDOCAINE 4% GEL PATCH	Dr. Sabharwal's Wound Care	102399b6-5be9-ee5e-e063-6394a90a3198	2026-04-02	Warnings	Exact identifier application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVING	LIDOCAINE HYDROCHLORIDE	Scyberco Ltd	ac8eac04-ed5b-4c8e-9f9b-54d160b74606	2026-04-02	Warnings	Exact identifier application number: M017
FifthPulse Hydrocortisone	HYDROCORTISONE	WeCare Products LLC	f1fcb045-4a15-431b-9617-67eae9f87fbd	2026-04-02	Warnings	Exact identifier application number: M017
ANIXIKE Cream	MENTHOL 5% CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	4e8510e6-c0c7-bf6b-e063-6294a90a3b00	2026-04-02	Warnings	Exact identifier application number: M017
RAPID RELIEF	0.025% CAPSAICIN PAIN PATCH	83569	4ed549e8-0062-fb03-e063-6294a90aac65	2026-04-02	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HCL AND ZINC ACETATE	CVS Pharmacy	7e921988-ec66-38dc-e053-2a91aa0a7346	2026-04-01	Warnings	Exact identifier application number: M017
The Best Numbing Cream	TBNC	The Best Numbing Cream LLC	4ca3923b-f586-0aaf-e063-6294a90a16c1	2026-03-31	Warnings	Exact identifier application number: M017
ChapStick Classic Medicated	EXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALM	Suave Brands Co., LLC	42798a6c-2d7e-80f6-e063-6294a90a105f	2026-03-31	Warnings	Exact identifier application number: M017
Roll-On Pain Relief Liquid	LIDOCAINE HCL	HyVee Inc	4da6f6fb-b182-360f-e063-6294a90abdf3	2026-03-31	Warnings	Exact identifier application number: M017
Hand Sanitizer	ALCOHOL	ProStat First Aid	4e54aecb-190f-3866-e063-6294a90a810a	2026-03-31	Warnings	Exact identifier application number: M017
Burn Mist	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	c53ab9dd-351a-400b-b873-4f396e0af54d	2026-03-31	Warnings	Exact identifier application number: M017
Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving	LIDOCAINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	f7faddb2-5153-4fdd-a5ef-778182cef460	2026-03-31	Warnings	Exact identifier application number: M017
ZENOL COOL	METHYL SALICYLATE, L-MENTHOL	BA TRADE INC	4e5c45f4-88ce-3a13-e063-6394a90a2a09	2026-03-31	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	091451fb-e30a-0012-e063-6394a90a3ba8	2026-03-31	Warnings	Exact identifier application number: M017
Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and Mint	MENTHOL	Chattem, Inc.	b16ba9c2-23bf-4fdf-b44b-7abb9fec1911	2026-03-31	Warnings	Exact identifier application number: M017
DR.PABU NUMBING	LIDOCAINE 5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4e3a3c6c-4821-76ea-e063-6294a90a8f96	2026-03-30	Warnings	Exact identifier application number: M017
Doctor Jiao Antifungal Cream	MICONAZOLE NITRATE	Jiangxi Haiwei Pharmaceutical Co., Ltd.	4e3b231e-0642-bf63-e063-6394a90a905b	2026-03-30	Warnings	Exact identifier application number: M017
CVS Muscle Balm and Roll-On	CAMPHOR, MENTHOL	CVS Pharmacy	4e40025a-070a-508e-e063-6394a90af5d7	2026-03-30	Warnings	Exact identifier application number: M017
REGENECARE HA	LIDOCAINE HCL	MPM Medical LLC	c3eec066-38e8-4617-b34d-2f72ffb7a324	2026-03-30	Warnings	Exact identifier application number: M017
Softlips Naturals Medicated Matcha Honey	CAMPHOR, MENTHOL	The Mentholatum Company	4e03a721-73f3-b2f2-e063-6394a90a44e6	2026-03-27	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