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 138 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
basic care daytime severe cold and flu nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f2	2024-11-15	Warnings	Exact identifier application number: M012
Rompe Pecho EX	GUAIFENESIN	Efficient Laboratories Inc	89ea23a5-0da7-407e-83d9-77a0b562f3af	2024-11-14	Warnings	Exact identifier application number: M012
basic care daytime cold and flu nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	ceb342da-ff6d-4c19-9f78-0033d028075e	2024-11-14	Warnings	Exact identifier application number: M012
Topcare Nite Time Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	efb8e0e2-0795-4f4a-8ca6-955f33bee143	2024-11-14	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal four	PHENYLEPHRINE HYDROCHLORIDE	Amerisource Bergen	a3d637dc-d957-458c-8a75-f948601a31aa	2024-11-14	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	ec8db98f-4fd1-4644-b76f-ff04f72e87f4	2024-11-13	Warnings	Exact identifier application number: M012
dg health tussin	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, LLC	6f9b8267-1e0b-430b-8e44-06408ae82ea4	2024-11-13	Warnings	Exact identifier application number: M012
Walgreens Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walgreens	b60e2cf9-11ec-469e-e053-2a95a90a712a	2024-11-13	Warnings	Exact identifier application number: M012
Kroger Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Kroger Company	69333774-3cf4-384d-e053-2a91aa0a48b3	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	H. E. Butt Grocery Company	6403fe3d-d82b-f4d5-e053-2991aa0ac7d6	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	Topco Associates LLC	a2929bcb-fa81-4f15-b087-a9996b5e7d1f	2024-11-13	Warnings	Exact identifier application number: M012
Equate Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walmart	6271bb48-74b2-eb57-e053-2991aa0afd1b	2024-11-13	Warnings	Exact identifier application number: M012
Equaline Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	United Natural Foods, Inc. dba UNFI	6bf341e0-94b1-08ff-e053-2991aa0af634	2024-11-13	Warnings	Exact identifier application number: M012
Good Sense Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Good Sense	cd25e250-bb8b-7e83-e053-2a95a90a2639	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd	440a00b1-7960-0cc4-e054-00144ff8d46c	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd.	c6f207e8-bc0d-853a-e053-2a95a90ac623	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7fad8e65-34fe-5313-e053-2a91aa0a56f4	2024-11-13	Warnings	Exact identifier application number: M012
Dollar General Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7face5c7-f5c7-7eee-e053-2991aa0ab064	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	90622927-9682-4eb0-8c7f-894230b3dda4	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca	2024-11-13	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