Sinus Pressure and Congestion Relief PE

Product NDC: 11822-4530
11-digit product format: 118224530
Labeler code: 11822
Product ID: 11822-4530_ccdb8082-3098-43a0-872b-39a4d649605b
Type: HUMAN OTC DRUG
Nonproprietary name: Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rite Aid Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-01-14
Substance: PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10 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 Pressure and Congestion Relief PE
Brand name suffix: Maximum Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1049182	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
fccea3c5-42af-4939-82bc-d9409b75f91f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11822-4530-2	Sinus Pressure and Congestion Relief PEMaximum Strength	3 in 1 CARTON	TABLET, FILM COATED	3	20
11822-4530-2	Sinus Pressure and Congestion Relief PEMaximum Strength	24 in 1 BLISTER PACK	TABLET, FILM COATED	24	20
11822-4530-4	Sinus Pressure and Congestion Relief PEMaximum Strength	1 in 1 CARTON	TABLET, FILM COATED	1	20
11822-4530-4	Sinus Pressure and Congestion Relief PEMaximum Strength	18 in 1 BLISTER PACK	TABLET, FILM COATED	18	20
11822-4530-7	Sinus Pressure and Congestion Relief PEMaximum Strength	18 in 1 BLISTER PACK	TABLET, FILM COATED	18	20
11822-4530-7	Sinus Pressure and Congestion Relief PEMaximum Strength	2 in 1 CARTON	TABLET, FILM COATED	2	20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]	7
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]	7
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]	7
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, COATED [RITE AID]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-4530	SINUS PRESSURE AND CONGESTION RELIEF PE MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION]	19	Current NDC, Legacy NDC, 6 package rows	20250512_fccea3c5-42af-4939-82bc-d9409b75f91f.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 136 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NightTime Sinus	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	0f3b1404-9252-470a-aa8c-b360c85731f3	2024-11-25	Warnings	Exact identifier application number: M012
Maximum Strength-Cough and Chest Congestion DM	MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	d1830989-fe82-4f08-8618-78979fcef568	2024-11-25	Warnings	Exact identifier application number: M012
ASP Daytime PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	b84f2392-0b24-4af0-80f7-c45454093f51	2024-11-25	Warnings	Exact identifier application number: M012
ASP Nighttime Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	d8756d1f-baf5-412d-a493-a1c051eae302	2024-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	508a65ee-42fa-4c0b-b24d-9faac6b0eba7	2024-11-24	Warnings	Exact identifier application number: M012
DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	cb68eef0-b027-4bf1-b78f-f31844a8c06c	2024-11-22	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	de2a64ce-c169-4162-b79e-d3809bea2147	2024-11-22	Warnings	Exact identifier application number: M012
12 Hour Nasal Decongestant Extra Moisturizing	NASAL SPRAY	WinCo Foods LLC	13fbde45-958c-455f-b766-f6a34342ee95	2024-11-21	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	a01abac3-c13e-40f2-ae98-34bd6c9b7504	2024-11-21	Warnings	Exact identifier application number: M012
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6	2024-11-21	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg	DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	028b025e-2dde-4bef-ba7b-61774e855b4b	2024-11-21	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	856cb3c3-8f32-4285-8c13-25f01779a31a	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Severe Cold and Flu Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE	PuraCap Pharmaceutical LLC	3375a059-2939-438e-92b5-a7f1952bbb22	2024-11-21	Warnings	Exact identifier application number: M012
NiteTime Cold/Flu, Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	9033bf94-f444-4488-b717-050d04dee388	2024-11-21	Warnings	Exact identifier application number: M012
Day and Night Sinus Relief Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	4b554ce8-9a6a-444f-b5ea-63359bbc0653	2024-11-21	Warnings	Exact identifier application number: M012
Day Severe Cold and Night Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores, Inc.	7492b381-9eca-4b07-b356-63fdaea14f81	2024-11-21	Warnings	Exact identifier application number: M012
Severe sinus Congestion Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	e173bec9-14df-4535-a023-47d8cda8d4ec	2024-11-21	Warnings	Exact identifier application number: M012
COLD FLU and SORE THROAT RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	1161e5dc-0677-4fb9-964f-971a508098b6	2024-11-21	Warnings	Exact identifier application number: M012
Night Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Retail Business Services, LLC	fc8c70d6-6be5-4f12-84b0-125fc82149ec	2024-11-21	Warnings	Exact identifier application number: M012
12 Hour Original Nasal Decongestant	NASAL SPRAY	WinCo Foods LLC	b3b6065a-56da-45e9-b89d-f6553bc181c9	2024-11-21	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049182	phenylephrine HCl 10 MG Oral Tablet	PSN	fccea3c5-42af-4939-82bc-d9409b75f91f	20
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	fccea3c5-42af-4939-82bc-d9409b75f91f	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-4530-2	11822453002	3 BLISTER PACK in 1 CARTON (11822-4530-2) / 24 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2005-01-14	0000-00-00	No	No	Current
11822-4530-4	11822453004	1 BLISTER PACK in 1 CARTON (11822-4530-4) / 18 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2005-01-14	0000-00-00	No	No	Current
11822-4530-7	11822453007	2 BLISTER PACK in 1 CARTON (11822-4530-7) / 18 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2005-01-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid 44-453	Rite Aid Corporation \| LNK International, Inc.	2026-05-01	HUMAN OTC DRUG LABEL	20