Nasal Decongestant PE and Pain Relief

Product NDC: 67091-209
11-digit product format: 670910209
Labeler code: 67091
Product ID: 67091-209_33a2684a-dafd-4b92-9e9f-eca4e03337e3
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: WinCo Foods, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-06-23
Substance: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 5 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Nasal Decongestant PE and Pain Relief
Brand name suffix: Maximum Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1046378	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
fab51b36-1c2e-4c97-932c-dacfaf55935a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67091-209-24	Nasal Decongestant PE and Pain ReliefMaximum Strength	12 in 1 BLISTER PACK	TABLET	12		15
67091-209-24	Nasal Decongestant PE and Pain ReliefMaximum Strength	2 in 1 CARTON	TABLET	2		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67091-209	NASAL DECONGESTANT PE AND PAIN RELIEF MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WINCO FOODS, LLC]	14	Current NDC, Legacy NDC, 2 package rows	20250512_fab51b36-1c2e-4c97-932c-dacfaf55935a.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 1 of 195 · 3,890 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Intense Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	03aa43fd-4962-4c2c-9edd-e422a629a0e3	2026-08-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f311b56f-b959-4070-9b23-82c642dd98b8	2026-08-06	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	2ed25f69-89ef-4c50-946a-7e7b9df1ca8a	2026-08-06	Warnings	Exact identifier application number: M012
Eucamint	MENTHOL, CAMPHOR	Indiana Botanic Gardens	d79bc8de-9efb-4996-a55c-accda0f8edb2	2026-08-06	Warnings	Exact identifier application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc	b745f45d-2042-4daa-9932-241836d7734b	2026-08-06	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	NUVICARE LLC	6713fdff-0e4e-4a9d-b218-34f786339c57	2026-08-06	Warnings	Exact identifier application number: M012
Daytime Cold, Nighttime Cold multi-symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	3b462a5d-d48b-4b73-b5d4-d7944730bbdd	2026-08-06	Warnings	Exact identifier application number: M012
Sinufrin Quick Relief Decongestant	SINUFRIN	Neilmed pharmaceuticals Inc.	0c36a34e-462d-713c-e063-6294a90a1776	2026-08-05	Warnings	Exact identifier application number: M012
No Drip	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	e9b799ad-9164-7f30-e053-2a95a90a00c5	2026-08-05	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreen Company	78edeb7a-4712-4f04-9d76-d5b2d20ce76d	2026-08-04	Warnings	Exact identifier application number: M012
CareOne Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	c9342ad2-84dc-4f4c-9b05-c6e5c1c7989e	2026-08-04	Warnings	Exact identifier application number: M012
dg health cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	3d8ce88e-9f40-4b58-a811-160ddbfb8112	2026-08-04	Warnings	Exact identifier application number: M012
ValuRx Dye Free Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Shield Pharmaceuticals Corp	ca60a413-b02e-48ce-985d-4d415780c679	2026-08-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	150b68ba-3ed4-4533-9118-74e76eaf6e48	2026-08-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	ce393bff-498b-42e6-a41c-bbfbc58fb42c	2026-08-04	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	3b8662bf-3abb-4e54-af9c-5fa1d2e19003	2026-08-04	Warnings	Exact identifier application number: M012
Mucus Relief PE	GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	cb1c1922-5dc6-520d-e77e-e951726d9701	2026-08-04	Warnings	Exact identifier application number: M012
Chest Congestion Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	DOLGENCORP, LLC	da053bc3-e790-4ae9-a406-2629640e97e7	2026-08-04	Warnings	Exact identifier application number: M012
Cold and Flu plus Congestion Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WALMART INC.	1236b463-0073-44b5-a516-5b7c06a40887	2026-08-04	Warnings	Exact identifier application number: M012
daytime nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	80aae1c3-a616-442b-842e-177db957a69c	2026-08-04	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046378	acetaminophen 325 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	fab51b36-1c2e-4c97-932c-dacfaf55935a	15
1046378	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	fab51b36-1c2e-4c97-932c-dacfaf55935a	15
1046378	APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	fab51b36-1c2e-4c97-932c-dacfaf55935a	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67091-209-24	67091020924	2 BLISTER PACK in 1 CARTON (67091-209-24) / 12 TABLET in 1 BLISTER PACK	2 blister pack	2005-06-23	0000-00-00	No	No	Current