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 8 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Overnight Cold and Flu Clear and Cool	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	CVS PHARMACY, INC	2497a011-d7a0-4d69-97e2-bbf25a99b1cc	2026-08-17	Warnings	Exact identifier application number: M012
Mucus Relief Cough Cold Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	H E B	3ef949f5-ac8c-44be-b04d-6996fa59a94b	2026-08-17	Warnings	Exact identifier application number: M012
Sinus PE Head Congestion and Mucus	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Better Living Brands, LLC	28a4ec37-11dd-4134-81aa-851f081bf088	2026-08-17	Warnings	Exact identifier application number: M012
CVS Health No Drip	NASAL MIST	CVS PHARMACY,INC.	60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa	2026-08-17	Warnings	Exact identifier application number: M012
Daytime Cold and Cough and NightTime Cold and Congestion Childrens	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Walgreens	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2026-08-17	Warnings	Exact identifier application number: M012
CVS Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	CVS HEALTH	f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6	2026-08-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	23750ea1-18a4-bfa7-e063-6394a90afd09	2026-08-16	Warnings	Exact identifier application number: M012
Daytime Nighttime	ACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	KROGER COMPANY	30d50bbe-0a14-c985-e063-6294a90a47b3	2026-08-16	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	77f87e19-a9d5-479d-9434-bbde13210bfb	2026-08-15	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. DBA Leader	b1c2055b-4b5a-4fa2-b600-8930c9c8524c	2026-08-15	Warnings	Exact identifier application number: M012
Nighttime HBP Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY	146c9a62-0418-4b5d-9074-5be8a05f3f93	2026-08-15	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	610accad-2f8b-4605-9357-a58e6e18d417	2026-08-15	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength, Non-Drowsy	PSEUDOEPHEDRINE HCL	Amerisource Bergen	1fdb1ba5-4072-4baf-9e30-f01d57bf6d82	2026-08-15	Warnings	Exact identifier application number: M012
Cold and Flu Night	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	32c67914-d7cf-40ee-8682-0ba8ed691287	2026-08-15	Warnings	Exact identifier application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY	27820bce-6638-4f17-ac66-62b02b76bec3	2026-08-14	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE	CVS PHARMACY, INC.	004e104b-d6ff-48d5-8685-cd1bff45399a	2026-08-14	Warnings	Exact identifier application number: M012
CHILDRENS DIMETAPP COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	7babf4f6-ca0a-44a7-b1ea-d60e20d36f15	2026-08-14	Warnings	Exact identifier application number: M012
Nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	e7c8ffed-83b8-4088-b72c-d937e93f8b54	2026-08-14	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM and Overnight Cold and Flu	DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL	CVS	75520b77-d40b-4f43-b92a-7a3eba5b493f	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	bb24c298-1d00-4378-8de3-b4056220fa75	2026-08-14	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