Sinus Congestion and Pain

Product NDC: 41163-664
11-digit product format: 411630664
Labeler code: 41163
Product ID: 41163-664_4f9dc1f8-cb74-45c8-b132-bd31a373322e
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: United Natural Foods, Inc. dba UNFI
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-07-26
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: Sinus Congestion and Pain
Brand name suffix: Daytime
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
f3fc270a-92fc-46d5-b187-44e875c3abb9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41163-664-08	Sinus Congestion and PainDaytime	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		15
41163-664-08	Sinus Congestion and PainDaytime	2 in 1 CARTON	TABLET, FILM COATED	2		15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41163-664	SINUS CONGESTION AND PAIN DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]	14	Current NDC, Legacy NDC, 2 package rows	20250217_f3fc270a-92fc-46d5-b187-44e875c3abb9.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 72 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DayTime Cold/Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	04f9134e-1311-4843-90db-9244b9e61e1d	2025-12-19	Warnings	Exact identifier application number: M012
Nighttime Cold/Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	029e6215-b72d-4fd0-8918-db1abcc4490a	2025-12-19	Warnings	Exact identifier application number: M012
DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	5f680f37-b3db-450f-b8ca-f9e31a04dc04	2025-12-19	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Marc Glassman, Inc.	e916ef86-ca73-42dd-83dc-6033f56d96f2	2025-12-19	Warnings	Exact identifier application number: M012
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Discount Drug Mart	e243033b-6603-4c3e-a330-e7c7de51f69d	2025-12-19	Warnings	Exact identifier application number: M012
CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	6fa4f913-de83-4175-9dad-0dedab5b69a1	2025-12-19	Warnings	Exact identifier application number: M012
Day-Time COLD/FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	Discount Drug Mart	426db906-9aa4-448f-a361-09c1516efc25	2025-12-19	Warnings	Exact identifier application number: M012
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Discount Drug Mart	f17385bc-82bb-4183-a4c9-067d8afb3757	2025-12-19	Warnings	Exact identifier application number: M012
MAXIUM STRENGTH DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Discount Drug Mart	9654fdcd-d660-471f-bc5d-aa7dead7a4a8	2025-12-19	Warnings	Exact identifier application number: M012
Night Time Multi-Symptom Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Discount Drug Mart	8148c2b1-f6ec-4597-8e18-a6597cda5705	2025-12-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	NUVICARE LLC	621ba20e-75c5-42fb-9692-7800f764c978	2025-12-19	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL 10 MG	NUVICARE LLC	4cde41dd-a0a7-45e7-aff3-ee9402dfdff2	2025-12-19	Warnings	Exact identifier application number: M012
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e	2025-12-19	Warnings	Exact identifier application number: M012
NeoTuss S/F Grape-Menthol Flavor	GUAIFENESIN, DEXTROMETHORPHAN HBR	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2f3df82c-1926-5238-e063-6294a90a7bbf	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss S/F Grape-Menthol Flavor	GUAIFENESIN, DEXTROMETHORPHAN HBR	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2fac3425-32f0-38d6-e063-6394a90a6e7a	2025-12-18	Warnings	Exact identifier application number: M012
NAFASOLINA	NAPHAZOLINE HYDROCHLORIDE	Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals	30cade3d-208f-8594-e063-6394a90ad2a0	2025-12-18	Warnings	Exact identifier application number: M012
Honey Lemon Flavor Cough Drop	HONEY LEMON FLAVOR COUGH DROP	Army & Air Force Exchange Service	20ac8a20-206c-0024-e063-6394a90a9d06	2025-12-18	Warnings	Exact identifier application number: M012
Menthol Flavor Cough Drop	MENTHOL FLAVOR COUGH DROP	Army & Air Force Exchange Service	20ace10f-4257-b20e-e063-6394a90a3c7b	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss Plus	DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2fabd782-14dc-1d1b-e063-6394a90af428	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss Plus	DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2f3c6b38-7236-899b-e063-6294a90aabde	2025-12-18	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	f3fc270a-92fc-46d5-b187-44e875c3abb9	15
1046378	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	f3fc270a-92fc-46d5-b187-44e875c3abb9	15
1046378	APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	f3fc270a-92fc-46d5-b187-44e875c3abb9	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41163-664-08	41163066408	2 BLISTER PACK in 1 CARTON (41163-664-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2005-07-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Equaline 44-466C	United Natural Foods, Inc. dba UNFI \| LNK International, Inc.	2026-02-09	HUMAN OTC DRUG LABEL	15