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 152 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough Drops	MENTHOL	Topco Associates LLC	eff16ba3-7e30-aa93-e053-2995a90a64cb	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	ebf6bcf5-9384-052a-e053-2a95a90a30a5	2024-10-07	Warnings	Exact identifier application number: M012
Rompe Pecho SF Flu SF Flu	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Efficient Laboratories Inc	06eac696-e8f6-ac50-e063-6394a90a2ed6	2024-10-07	Warnings	Exact identifier application number: M012
dg health nasal four	PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	ceeeb016-8e46-40b8-9923-8a4270475f45	2024-10-04	Warnings	Exact identifier application number: M012
Topcare Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	99bc8829-167b-4cf8-8421-57da369f24cd	2024-10-04	Warnings	Exact identifier application number: M012
basic care nasal	PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	858648f6-f454-4008-9ea8-ad060c217833	2024-10-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Navajo Manufacturing Company Inc.	f6068011-ad56-59b4-e053-2995a90ac016	2024-10-03	Warnings	Exact identifier application number: M012
Benadryl Ultratabs	DIPHENHYDRAMINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76433e3c-142c-4704-8b2b-d602f008c377	2024-10-02	Warnings	Exact identifier application number: M012
Afrin	OXYMETAZOLINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	65bf1556-f234-9439-e053-2a91aa0a3194	2024-10-02	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Proficient Rx LP	4eab4344-d95e-4b19-a21e-9c8ad033863a	2024-10-01	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Proficient Rx LP	a910320b-0585-40bd-928c-0406346281d0	2024-10-01	Warnings	Exact identifier application number: M012
CareOne Nasal and Sinus Decongestant	PSEUDOEPHEDRINE HCL	American Sales Company	81b31070-9b03-4ce4-8aac-a334544842ae	2024-10-01	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	Proficient Rx LP	20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d	2024-10-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	1bec5167-5fc5-2405-e063-6294a90a5358	2024-09-30	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	A-S Medication Solutions	19b3db33-86d1-48f3-9525-c7c87a4b6899	2024-09-29	Warnings	Exact identifier application number: M012
nasal decongestant maximum strength non drowsy	PSEUDOEPHEDRINE HCL	Meijer Distribution Inc	8a68ca99-fd76-409a-9769-88830e8720a8	2024-09-28	Warnings	Exact identifier application number: M012
good neighbor pharmacy tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	58687394-b6d2-4d51-bde0-8f2cfa3fe909	2024-09-27	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Amerisource Bergen	faee3aae-e819-4084-a127-3449be353b13	2024-09-27	Warnings	Exact identifier application number: M012
Tesalon Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL	OPMX LLC	2309620a-ccbc-41e9-e063-6394a90a9520	2024-09-26	Warnings	Exact identifier application number: M012
adult cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Meijer, Inc.	b11c4cee-bbb5-4585-9d38-6787553e13a0	2024-09-26	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