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 107 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACTIDOGESIC	DEXBROMPHENIRAMINE MALEATE, ACETAMINOPHEN	ACTIPHARMA, LLC	697da3f9-9888-4d41-ba83-87ca9bf1e54b	2025-08-18	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Rite Aid Corporation	5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a0	2025-08-18	Warnings	Exact identifier application number: M012
MAJOR NASAL DECONGESTANT	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	4b78b9af-0975-43f8-8b44-daddef0478be	2025-08-15	Warnings	Exact identifier application number: M012
Dr Simi Mucus Relief Expectorant	GUAIFENESIN	Farmacias De Similares TX LLC	3c6d0e75-a685-6020-e063-6294a90a5c1b	2025-08-15	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Rite Aid Corporation	25bf4390-23f7-4bb6-b86e-c40eaf8d92da	2025-08-15	Warnings	Exact identifier application number: M012
Childrens Chewable Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2cac72be-4830-ad49-e063-6394a90a7832	2025-08-14	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTH	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AMERISOURCE BERGEN	2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e	2025-08-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walmart Inc.	16fae164-28db-8ef1-e063-6294a90ab5da	2025-08-12	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Original Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	fbece335-a7e5-4732-a086-561b23741579	2025-08-12	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Original Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	779ddb89-b6e2-4bfb-bcb5-8c7ec916675a	2025-08-12	Warnings	Exact identifier application number: M012
Equaline Nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	d7fa1720-eac4-4e82-9401-77215ce4f545	2025-08-12	Warnings	Exact identifier application number: M012
Diabetic Tussin DM Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	MEDTECH PRODUCTS INC	a10a3b33-7503-4334-8ed7-2bb881df4327	2025-08-08	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health, Inc	26a55d74-f772-5d17-e063-6394a90a5583	2025-08-07	Warnings	Exact identifier application number: M012
Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	b7434978-44a8-4c51-979d-0bc446461e43	2025-08-06	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	2025-08-06	Warnings	Exact identifier application number: M012
childrens cold cough dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Publix Super Markets Inc	6efe7097-2a99-4654-9d94-b47f2e64d19d	2025-08-05	Warnings	Exact identifier application number: M012
Quality Choice Throat Soothing Drops Creamy Strawberry	PECTIN	Chain Drug Marketing Association, Inc.	3b7548ee-7cd3-62c3-e063-6294a90a0612	2025-08-03	Warnings	Exact identifier application number: M012
Vaporizing chest rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	LJ Pharma	065bb666-e482-4e96-ac75-c6577dcc5b48	2025-08-01	Warnings	Exact identifier application number: M012
Nighttime Cough-Kids	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Genexa	024bb864-4214-1d8b-e063-6394a90aa573	2025-08-01	Warnings	Exact identifier application number: M012
Antigrip Cough and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Pharmadel LLC	3b53e5fc-f258-c2b9-e063-6394a90ab500	2025-08-01	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