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 111 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medicated Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Meijer Distribution Inc	75c6fcd5-185c-4203-b604-19ce801c865f	2024-12-18	Warnings	Exact identifier application number: M017
MEIJER PAIN RELIEF PATCHES	LIDOCAINE	Meijer Distribution Inc	aa5da66d-3ba9-4120-be35-44bec475761a	2024-12-18	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Roll-On	LIDOCAINE 4%	CVS Pharmacy	8a9757e3-0bfc-a1e2-e053-2a95a90a6da3	2024-12-18	Warnings	Exact identifier application number: M017
Dollar General Cold-Hot Medicated Patches	MENTHOL	DOLGENCORP, LLC	c6e0388b-af9e-4e51-8f94-6788185c31a0	2024-12-18	Warnings	Exact identifier application number: M017
THERA CARE PAIN THERAPY	LIDOCAINE	Veridian Healthcare	e023bb5a-a4bc-4681-a1f4-48ca0d2cb102	2024-12-18	Warnings	Exact identifier application number: M017
TheraCare Medicated Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Veridian Healthcare	f6f3c9c0-d6e3-75a3-e053-6294a90a1965	2024-12-18	Warnings	Exact identifier application number: M017
Good Sense Hot and Cold Medicated Patch	MENTHOL	GOOD SENSE	1b16c3e5-a29f-4043-94e6-0a0e0ea3d93e	2024-12-18	Warnings	Exact identifier application number: M017
Hunter Beach 4%	LIDOCAINE	HUNTERS BEACH LIFE	f2ef9c12-6e42-486b-b6f2-0ad534e94294	2024-12-18	Warnings	Exact identifier application number: M017
Hunter Beach 4%	LIDOCAINE	HUNTERS BEACH LIFE	05a9605b-0d01-4333-8e54-7202e7c31c49	2024-12-18	Warnings	Exact identifier application number: M017
Ultra Strength Muscle Rub	CAMPHOR, MENTHOL, METHYL SALICYLATE	The Mentholatum Company	32b64985-0e2f-49ee-9840-946d7279fee7	2024-12-17	Warnings	Exact identifier application number: M017
WellPatch Warming Pain Relief	CAPSAICIN	The Mentholatum Company	ec583129-55fc-4ab1-94e5-9c900b5d95ef	2024-12-17	Warnings	Exact identifier application number: M017
CVS Health Cold and Hot Pain Relieving Extra Strength	MENTHOL, METHYL SALICYLATE	CVS Pharmacy	1ca1a631-cb2c-46cd-bd41-05469b08d208	2024-12-17	Warnings	Exact identifier application number: M017
Mentholatum Pain Relieving	MENTHOL, METHYL SALICYLATE	The Mentholatum Company	0056b952-9870-485a-9f35-f985472875a9	2024-12-17	Warnings	Exact identifier application number: M017
Mentholatum Lidocaine Heat	LIDOCAINE HCL	The Mentholatum Company	cc2ef25a-b569-4d48-a666-899f710b4b34	2024-12-17	Warnings	Exact identifier application number: M017
Rite Aid Muscle Rub Ultra Strength	CAMPHOR, MENTHOL, METHYL SALICYLATE	Rite Aid Corporation	039fff40-b5ba-42cb-932c-8a70ca92759d	2024-12-17	Warnings	Exact identifier application number: M017
Signature Care Cold and Hot Medicated	MENTHOL	Safeway	88f59f95-0a7c-458c-949c-0dff16ad94e4	2024-12-17	Warnings	Exact identifier application number: M017
Equate Cool and Heat	MENTHOL, METHYL SALICYLATE	Wal-Mart Stores Inc	c5ab2426-eeca-4ba4-9f00-7790d2176471	2024-12-17	Warnings	Exact identifier application number: M017
Equate Capsaicin Pain Relieving	CAPSAICIN	Wal-Mart Stores Inc	745b2cf5-2599-4383-818b-19fed248a11f	2024-12-17	Warnings	Exact identifier application number: M017
CVS Health Muscle Rub Ultra Strength	CAMPHOR, MENTHOL, METHYL SALICYLATE	CVS Pharmacy	4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a	2024-12-17	Warnings	Exact identifier application number: M017
DG Health Maximum Strength Pain Relieving Cleansing	BENZALKONIUM CL, LIDOCAINE HCL	Dollar General Corporation	64f69315-77a3-49dc-940d-efd7a29c6645	2024-12-17	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