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 137 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walmart	6271bb48-74b2-eb57-e053-2991aa0afd1b	2024-11-13	Warnings	Exact identifier application number: M012
Equaline Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	United Natural Foods, Inc. dba UNFI	6bf341e0-94b1-08ff-e053-2991aa0af634	2024-11-13	Warnings	Exact identifier application number: M012
Good Sense Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Good Sense	cd25e250-bb8b-7e83-e053-2a95a90a2639	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd	440a00b1-7960-0cc4-e054-00144ff8d46c	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd.	c6f207e8-bc0d-853a-e053-2a95a90ac623	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7fad8e65-34fe-5313-e053-2a91aa0a56f4	2024-11-13	Warnings	Exact identifier application number: M012
Dollar General Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7face5c7-f5c7-7eee-e053-2991aa0ab064	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	90622927-9682-4eb0-8c7f-894230b3dda4	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca	2024-11-13	Warnings	Exact identifier application number: M012
WinCo Foods Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	WinCo Foods, LLC	d443a030-d3d6-40e0-8fe0-329de6bc494f	2024-11-13	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	954fe703-9a10-4354-8b71-4d98a22a0b9f	2024-11-13	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE	PHENYLEPHRINE HCL	A-S Medication Solutions	9d030767-dfd6-48b4-9b17-4e20c23915f3	2024-11-13	Warnings	Exact identifier application number: M012
Childrens SUDAFED PE Cold plus Cough	DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	20e45243-3989-413a-bcf1-49d754ff2e44	2024-11-12	Warnings	Exact identifier application number: M012
Tukol Cough And Cold Honey Flavor	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	a4b333dc-58da-45db-87b6-6fcb8fb542b8	2024-11-12	Warnings	Exact identifier application number: M012
daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	4b49137c-8fc9-43b7-b1a1-82e318237eb6	2024-11-12	Warnings	Exact identifier application number: M012
CVS Original Nasal Mist	OXYMETAZOLINE HCL	CVS PHARMACY, INC	e9c551a0-cd78-4272-b42f-36c096d26736	2024-11-12	Warnings	Exact identifier application number: M012
up and up cough plus chest congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Target Corporation	ed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c	2024-11-12	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	b33d104b-0b4d-40c6-8345-c2c740327331	2024-11-11	Warnings	Exact identifier application number: M012
Zephrex D	PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	5468a7e2-361b-494f-9ca3-1b62f3819f65	2024-11-11	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	American Sales Company	6c90fccf-0e6f-43df-9468-d8ece8ded009	2024-11-11	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