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 97 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GILTUSS DIABETIC DM	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	bd367ce1-996b-45bc-865e-b6aafe0ea7b0	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss DM	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	1a4fe686-3085-4543-bd6c-f20580b1df50	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss D Allergy and Congestion	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	8591003c-c2ec-df65-e053-2a91aa0a42fb	2025-10-09	Warnings	Exact identifier application number: M012
Gilphex	GUAIFENESIN, PHENYLEPHRINE HCL	Gil Pharmaceutical Corp.	e7c8fb97-02cf-4df6-b477-9ff69d6b675d	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	d9f26677-ddef-4098-b564-9aa5734e088b	2025-10-09	Warnings	Exact identifier application number: M012
Kalaya Breathe Easy Vaporizing Rub	VAPORIZING RUB	Avaria Health & Beauty Corp	7adf96b1-03af-a87b-e053-2a91aa0a4585	2025-10-08	Warnings	Exact identifier application number: M012
Equate Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Walmart Inc	01e1f418-c232-e89e-e063-6294a90abd35	2025-10-08	Warnings	Exact identifier application number: M012
Equate	OXYMETAZOLINE HCL	Walmart Inc	020942b1-59d4-a19d-e063-6394a90a5d87	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Assorted Flavors 80ct	MENTHOL	Dollar General	425d2e63-f5bc-45fb-b330-967ae64cfddb	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Cherry 200ct	MENTHOL	Dollar General Corporation	a17aece2-abd8-452a-9da8-2e303845900b	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Cherry 30ct	MENTHOL	Dollar General Corporation	b96268da-d6f2-41e4-ba04-ce419376f626	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Cherry 30ct	MENTHOL	Dollar General Corporation	51ccf39a-ae9b-4e6a-856c-002c296f5d07	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Honey Lemon 200ct	MENTHOL	Dollar General Corporation	8f8a9474-f388-4ede-85f2-86222b15ee58	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Honey Lemon 200ct	MENTHOL	Dollar General Corporation	f85f1a15-db7f-4bb5-9313-24702660054e	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Honey Lemon 30ct	MENTHOL	Dollar General Corporation	61a23ce6-5157-4076-afa7-6a79c62fe9e0	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Honey Lemon 30ct	MENTHOL	Dollar General Corporation	d5fb7d9e-b0f6-4424-bf67-9e72b50366b1	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Menthol 160ct	MENTHOL	Dollar General Corporation	9f9916f5-83ea-4f36-b8c2-c6fe1f77884b	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Menthol 80ct	MENTHOL	Dollar General Corporation	a23ec89a-de7e-4013-b85b-1593e18dc28e	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Menthol 160ct	MENTHOL	Dollar General Corporation	1833d3bf-6f01-4122-9f4d-4d8b2423fcbb	2025-10-08	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Menthol 30ct	MENTHOL	Dollar General Corporation	fbe92e39-6470-4634-b976-e316baa2c995	2025-10-08	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