Fortify

Product NDC: 70983-002
11-digit product format: 709830002
Labeler code: 70983
Product ID: 70983-002_4850561f-988a-f1a7-e063-6394a90a982b
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: OIL
Route: TOPICAL
Labeler: Saje Natural Business Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-10-16
Substance: MENTHOL
Active strength: 24 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Fortify
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	24 mg/mL

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0320a305-99d1-4909-94cc-cd6509ecb948	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70983-002-03	Fortify	30 mL in 1 BOTTLE, DROPPER	OIL	30	5
70983-002-03	Fortify	1 in 1 BOX	OIL	1	5
70983-002-04	Fortify	1 in 1 BOX	OIL	1	5
70983-002-04	Fortify	10 mL in 1 BOTTLE, DROPPER	OIL	10	5
70983-002-05	Fortify	1 in 1 BOX	OIL	1	5
70983-002-05	Fortify	6 mL in 1 BOTTLE, DROPPER	OIL	6	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70983-002	FORTIFY (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.]	4	Current NDC, Legacy NDC, 6 package rows	20231006_0320a305-99d1-4909-94cc-cd6509ecb948.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 138 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense night time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	89dc1423-d097-47a8-9025-eab5381cca26	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	10f9627b-edda-422a-b01f-7066f9c98335	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	17c3fe42-3c40-4405-80b7-b3f9e4aa8376	2024-11-11	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	1dd36aa7-f085-4350-8cf2-f9fa29b583e4	2024-11-11	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7f9f1d0-7498-461c-b4e8-4c92cf3feae8	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	bd079f5d-0a38-40e6-9661-e8236c88a24d	2024-11-11	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	PAI Holdings, LLC dba PAI Pharma	ff970fff-d1a3-4322-83b4-34e361431a1c	2024-11-11	Warnings	Exact identifier application number: M012
topcare tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	e1118592-30ac-4505-9f38-c6d395c4cf5b	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	624b8029-9fdb-4908-a13b-f9dd75030120	2024-11-11	Warnings	Exact identifier application number: M012
Biofreeze Colorless	MENTHOL	A-S Medication Solutions	cc1cba14-da40-4d7d-b522-b5c648798e96	2024-11-11	Warnings	Exact identifier application number: M012
foster and thrive nighttime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	298b7754-d0d8-496d-9949-4c346cb11e34	2024-11-11	Warnings	Exact identifier application number: M012
leader tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	b418c10c-528b-4395-944e-af959b639ec2	2024-11-10	Warnings	Exact identifier application number: M012
equaline adult tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	f7c753f8-4b12-4797-a599-736d597bc1bc	2024-11-10	Warnings	Exact identifier application number: M012
foster and thrive adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Strategic Sourcing Services LLC	f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7	2024-11-10	Warnings	Exact identifier application number: M012
dg health adult tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dolgencorp Inc	81f12484-ddf7-49c6-b530-3a81d62ab40d	2024-11-10	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Retail Business Services, LLC	230fa1ea-ae7c-425e-8447-79a90c96ae9e	2024-11-10	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	L. Perrigo Company	cb8a1d81-b1a3-4217-b157-9e5d398f202d	2024-11-09	Warnings	Exact identifier application number: M012
PhysiciansCare Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	Acme United Corporation	5e31b1ff-291f-7b8c-e053-2a91aa0aedbc	2024-11-09	Warnings	Exact identifier application number: M012
Duraflu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	55fffc1d-8449-4c28-a391-c6f60dd85622	2024-11-09	Warnings	Exact identifier application number: M012
Poly-Vent IR	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	ce0d8c45-446a-4df4-a36b-5000ba69d30d	2024-11-09	Warnings	Exact identifier application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70983-002-03	70983000203	1 BOTTLE, DROPPER in 1 BOX (70983-002-03) / 30 mL in 1 BOTTLE, DROPPER	2016-10-16	0000-00-00	No	No	Current
70983-002-04	70983000204	1 BOTTLE, DROPPER in 1 BOX (70983-002-04) / 10 mL in 1 BOTTLE, DROPPER	2016-10-16	0000-00-00	No	No	Current
70983-002-05	70983000205	1 BOTTLE, DROPPER in 1 BOX (70983-002-05) / 6 mL in 1 BOTTLE, DROPPER	2016-10-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fortify Antitussive (Cough Suppressant) Oil Blend Rub (30 ml, 10 ml, 6 ml)	Saje Natural Business Inc. \| Natures Formulae Health Products Ltd.	2026-01-13	HUMAN OTC DRUG LABEL	5