Dristan

Product NDC: 80070-400
11-digit product format: 800700400
Labeler code: 80070
Product ID: 80070-400_41e7cd3f-510d-0976-e063-6394a90abe9e
Type: HUMAN OTC DRUG
Nonproprietary name: OXYMETAZOLINE HYDROCHLORIDE
Dosage form: SPRAY
Route: NASAL
Labeler: Foundation Consumer Brands
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-08-17
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: .5 mg/mL
Pharmacologic classes: Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
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: Dristan
Brand name suffix: 12 hr
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OXYMETAZOLINE HYDROCHLORIDE	.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K89MJ0S5VY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1000990	Internal RxNorm lookup
1000996	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
522876fe-a412-4ca8-bfad-a313e3cbc1af	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e67be450-f8e4-4bc1-88bd-1259d379f55f	Product name	1	20210127
c53f3286-4062-4cf5-8355-399519c639a6	Product name	1	20170424
a993dfc5-f219-4460-bde6-30dd724d9ef0	Product name	1	20160818

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80070-400-05	Dristan12 hr	15 mL in 1 BOTTLE, SPRAY	SPRAY	15	3
80070-400-05	Dristan12 hr	1 in 1 CARTON	SPRAY	1	3
80070-400-15	Dristan12 hr	45 mL in 1 CARTON	SPRAY	45	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80070-400	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [FOUNDATION CONSUMER BRANDS]	2	Current NDC, Legacy NDC, 3 package rows	20241109_522876fe-a412-4ca8-bfad-a313e3cbc1af.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 21 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	bfec14d5-d9ce-4b9c-a803-3d01cb00b56c	2026-06-22	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	WinCo Foods, LLC	5f1aaa8e-c65f-43b3-9850-c60c1663d78f	2026-06-22	Warnings	Exact identifier application number: M012
DAY TIME INTENSE FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Meijer, Inc.	e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a	2026-06-22	Warnings	Exact identifier application number: M012
NO DRIP NASAL	PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	7a866cdf-1c0c-403a-afc8-0e99e0ce81aa	2026-06-22	Warnings	Exact identifier application number: M012
Maximum Strength Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	KROGER COMPANY	30d4c4b9-0f5f-0279-e063-6394a90af1b5	2026-06-19	Warnings	Exact identifier application number: M012
GoodMeds Nasal Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	6a8a961c-d2d2-428d-8af7-8527aae25c8a	2026-06-19	Warnings	Exact identifier application number: M012
equaline nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	United Natural Foods, Inc. dba UNFI	490766e7-1781-4b2b-a8f4-d4efb9fff560	2026-06-19	Warnings	Exact identifier application number: M012
Equate Nasal	PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	30f6d588-ad80-4348-a45f-77337e067bca	2026-06-19	Warnings	Exact identifier application number: M012
GUAIFENESIN	GUAIFENESIN	Cardinal Health 107, LLC	888b6a2e-6631-4585-a7fe-eb122eb51b23	2026-06-18	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Cold plus Flu Multi Symptom Day	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	5487b2e1-b0e5-0236-e063-6394a90a3a8b	2026-06-18	Warnings	Exact identifier application number: M012
Vaporizing Colds Rub	MENTHOL	Delon Laboratories (1990) Ltd	3ed8bc0c-c229-450b-a491-06b578c1b8ee	2026-06-18	Warnings	Exact identifier application number: M012
Allergy Childrens	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	218c447e-9ddd-428a-9b33-0acec35e0d1b	2026-06-17	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	WALMART INC.	a9d5f9f4-ddec-4ad6-ad06-4a612008bb68	2026-06-17	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	e49d2a0f-6588-439b-8a46-c073e0bc4f9a	2026-06-17	Warnings	Exact identifier application number: M012
COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway	ac0380ad-c9fa-4bda-ab84-c2e6aa672bdf	2026-06-17	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1a21cbb2-1ba5-414f-a31f-42b7a7bddae5	2026-06-16	Warnings	Exact identifier application number: M012
Tussin DM Regular	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AARNA USA, Inc.	5460c809-71c8-3ad6-e063-6294a90a4e4f	2026-06-16	Warnings	Exact identifier application number: M012
Equate Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	4b111580-cd20-43ec-9ff4-4b9f74f7d2e8	2026-06-16	Warnings	Exact identifier application number: M012
Sinus Congestion	PHENYLEPHRINE HCL	Chain Drug Marketing Association, Inc.	43a77f89-e66a-4db6-8067-f614c0e207df	2026-06-16	Warnings	Exact identifier application number: M012
severe sinus congestion relief Maximum Strength	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	51175d3e-e1c3-4e4d-ad32-61600e87568c	2026-06-16	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000996	Dristan 12-Hour 0.05 % Nasal Spray	PSN	522876fe-a412-4ca8-bfad-a313e3cbc1af	3
1000990	oxymetazoline HCl 0.05 % Nasal Spray	PSN	522876fe-a412-4ca8-bfad-a313e3cbc1af	3
1000996	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Dristan 12-Hour Nasal Spray]	SBD	522876fe-a412-4ca8-bfad-a313e3cbc1af	3
1000990	oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray	SCD	522876fe-a412-4ca8-bfad-a313e3cbc1af	3
1000996	Dristan 12-Hour 0.05 % Nasal Spray	SY	522876fe-a412-4ca8-bfad-a313e3cbc1af	3
1000996	Dristan 12-Hour 0.5 MG/ML Nasal Spray	SY	522876fe-a412-4ca8-bfad-a313e3cbc1af	3
1000990	oxymetazoline hydrochloride 0.05 % Nasal Spray	SY	522876fe-a412-4ca8-bfad-a313e3cbc1af	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80070-400-05	80070040005	1 BOTTLE, SPRAY in 1 CARTON (80070-400-05) / 15 mL in 1 BOTTLE, SPRAY		2021-08-17	0000-00-00	No	No	Current
80070-400-15	80070040015	45 mL in 1 CARTON (80070-400-15)	45 ml	2025-11-01		No	No	Current