Sinus Congestion and Pain

Product NDC: 37808-466
11-digit product format: 378080466
Labeler code: 37808
Product ID: 37808-466_106a8138-66f6-4058-a54d-7047783f57fa
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Phenylephrine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H E B
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 Non-Drowsy
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
e9dd2d7b-0a19-4a42-b51e-b9914f02406e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-466-08	Sinus Congestion and PainDaytime Non-Drowsy	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		15
37808-466-08	Sinus Congestion and PainDaytime Non-Drowsy	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 NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-466	SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]	14	Current NDC, Legacy NDC, 2 package rows	20250512_e9dd2d7b-0a19-4a42-b51e-b9914f02406e.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

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	e9dd2d7b-0a19-4a42-b51e-b9914f02406e	15
1046378	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	e9dd2d7b-0a19-4a42-b51e-b9914f02406e	15
1046378	APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	e9dd2d7b-0a19-4a42-b51e-b9914f02406e	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-466-08	37808046608	2 BLISTER PACK in 1 CARTON (37808-466-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2005-07-26	0000-00-00	No	No	Current