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

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: 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 9 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS PHARMACY, INC.	f4020c08-29f6-4609-834e-191ce6885130	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Cough, Flu Plus Sore Throat Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	95203001-7ca6-4513-83a3-9ef17855bc0f	2026-08-14	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	81d26e9c-b713-4fb3-b0a5-68526bad230e	2026-08-14	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	212acd54-6ff0-446a-a3bb-3b40e1279711	2026-08-13	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	e9d0b6f9-e9f3-431c-9f34-4d63108282a1	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Caramel Apple Cough Drops	MENTHOL	Bestco	58eee9b4-d696-995f-e063-6294a90a5db0	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Pumpkin Spice Cough Drops	MENTHOL	Bestco	58ef6619-9087-5f41-e063-6294a90a7da6	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Bourbon Honey Cough Drops	MENTHOL	Bestco	58efdf29-83ea-03b9-e063-6294a90ad306	2026-08-13	Warnings	Exact identifier application number: M012
daytime nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Amazon.com Services LLC	9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e	2026-08-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	1e3c81b0-05de-4c4a-8579-f301f14626b3	2026-08-13	Warnings	Exact identifier application number: M012
Tussin DM Daytime Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d59f6c64-8311-48ba-90d1-8000b04bfcda	2026-08-13	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5578e6-7e67-c467-e063-6294a90a6e0b	2026-08-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f95220c5-e55c-4271-a267-d004ad2447bf	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	569b8efa-8458-49f7-a665-6b7016a10505	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY DYE FREE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7	2026-08-12	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	af35c833-316a-4d21-bd3a-9b71558cadbf	2026-08-12	Warnings	Exact identifier application number: M012
Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores Inc	cc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c	2026-08-11	Warnings	Exact identifier application number: M012
Best Health Maple Spice Cough Drops	MENTHOL	Bestco	58cfdacb-c713-220f-e063-6394a90acbfc	2026-08-11	Warnings	Exact identifier application number: M012
7 Select Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	7-ELEVEN	f9475972-0cbb-45c5-9e49-09569f1665a7	2026-08-11	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e3	2026-08-10	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