Sinus PE Pressure plus Pain

Product NDC: 59779-802
11-digit product format: 597790802
Labeler code: 59779
Product ID: 59779-802_7a903151-4f47-4111-b0f1-5c716c3d7651
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: CVS Pharmacy
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-06-23
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 PE Pressure plus Pain
Brand name suffix: MAXIMUM STRENGTH
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
a3b073b4-494c-4531-b08e-475c86ba321d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59779-802-08	Sinus PE Pressure plus PainMAXIMUM STRENGTH	2 in 1 CARTON	TABLET	2		16
59779-802-08	Sinus PE Pressure plus PainMAXIMUM STRENGTH	12 in 1 BLISTER PACK	TABLET	12		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-802	SINUS PE PRESSURE PLUS PAIN MAXIMUM STRENGTH (ACETAMINOPHEN, PHENYLEPHRINE HCL) TABLET [CVS PHARMACY]	14	Current NDC, Legacy NDC, 2 package rows	20240727_a3b073b4-494c-4531-b08e-475c86ba321d.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 15 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
nighttime cough dm	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	5a45b4c2-6a15-40b4-9ac6-d1554244ec42	2026-07-23	Warnings	Exact identifier application number: M012
DAY TIME NITE TIME INTENSE FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	6372cbdd-a3a3-499d-91ce-53bcdb83e739	2026-07-23	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	df6e522c-3e30-4aa0-8ab9-3b579c80bcad	2026-07-22	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba	2026-07-22	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5386c1-e45d-9dcb-e063-6294a90aff07	2026-07-22	Warnings	Exact identifier application number: M012
Allergy plus Sinus Headache	ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG	Shield Pharmaceuticals Corp	772d0184-8c41-40f1-bbef-7e68692eec66	2026-07-22	Warnings	Exact identifier application number: M012
good sense allergy	DIPHENHYDRAMINE HCL	L. Perrigo Company	bf5039a0-2109-41a2-84a9-b5167d0a93da	2026-07-22	Warnings	Exact identifier application number: M012
Congestion and Headache	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	432c3ec4-7595-4213-94e3-ce41af91804e	2026-07-21	Warnings	Exact identifier application number: M012
SKAPEMED ORIGINAL NASAL	NAPHAZOLINE HCL 0.05% ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a208a1f-f6e8-0b4a-e063-6294a90a10c8	2026-07-21	Warnings	Exact identifier application number: M012
SERYNTH FAST RELIEF NASAL	NAPHAZOLINE HCL 0.05% FAST RELIEF NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4abdc0-aded-1b8a-e063-6394a90a9b56	2026-07-21	Warnings	Exact identifier application number: M012
DERMFREE ORIGINAL NASAL	NAPHAZOLINE HCL0.05%ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d0c03-7d8f-76cb-e063-6394a90a938c	2026-07-21	Warnings	Exact identifier application number: M012
DERMFREE ORIGINAL NASAL	NAPHAZOLINE HCL 0.05%ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d3a2b-a4ed-c736-e063-6394a90a96df	2026-07-21	Warnings	Exact identifier application number: M012
Severe Cough and Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	791eaac1-ddb5-40e2-9040-52dfadc30e06	2026-07-21	Warnings	Exact identifier application number: M012
DRx Choice DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc.	9ab47b10-b1ed-4ae1-94e8-09d50e952bb0	2026-07-21	Warnings	Exact identifier application number: M012
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	P & L Development, LLC	17639c3b-5d36-41f5-bd0d-da29075abd09	2026-07-21	Warnings	Exact identifier application number: M012
NATUHEAL ORIGINAL NASAL	NAPHAZOLINE HCL 0.05% ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a470b9e-c83f-fb20-e063-6294a90a2f13	2026-07-20	Warnings	Exact identifier application number: M012
TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	1c444202-19e9-8d04-e063-6394a90a9294	2026-07-20	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS HONEY LEMON	DISCOUNT DRUG MART	5565a581-e2b5-81a5-e063-6394a90af409	2026-07-20	Warnings	Exact identifier application number: M012
Best Choice Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	40e0b17a-5704-4203-8f0a-11b2fcf81f8f	2026-07-17	Warnings	Exact identifier application number: M012
Equate Daytime Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	ee1ef41d-b8be-42f3-9918-ccf1c0a80241	2026-07-17	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	a3b073b4-494c-4531-b08e-475c86ba321d	16
1046378	acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	a3b073b4-494c-4531-b08e-475c86ba321d	16
1046378	APAP 325 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	a3b073b4-494c-4531-b08e-475c86ba321d	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-802-08	59779080208	2 BLISTER PACK in 1 CARTON (59779-802-08) / 12 TABLET in 1 BLISTER PACK	2 blister pack	2005-06-23	0000-00-00	No	No	Current