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 109 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health, Inc	26a55d74-f772-5d17-e063-6394a90a5583	2025-08-07	Warnings	Exact identifier application number: M012
Daytime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	b7434978-44a8-4c51-979d-0bc446461e43	2025-08-06	Warnings	Exact identifier application number: M012
Tussin DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS Pharmacy	fc1e224c-5c57-43fc-ae6e-36aa0a4ae439	2025-08-06	Warnings	Exact identifier application number: M012
childrens cold cough dm	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Publix Super Markets Inc	6efe7097-2a99-4654-9d94-b47f2e64d19d	2025-08-05	Warnings	Exact identifier application number: M012
Quality Choice Throat Soothing Drops Creamy Strawberry	PECTIN	Chain Drug Marketing Association, Inc.	3b7548ee-7cd3-62c3-e063-6294a90a0612	2025-08-03	Warnings	Exact identifier application number: M012
Vaporizing chest rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	LJ Pharma	065bb666-e482-4e96-ac75-c6577dcc5b48	2025-08-01	Warnings	Exact identifier application number: M012
Nighttime Cough-Kids	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Genexa	024bb864-4214-1d8b-e063-6394a90aa573	2025-08-01	Warnings	Exact identifier application number: M012
Antigrip Cough and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Pharmadel LLC	3b53e5fc-f258-c2b9-e063-6394a90ab500	2025-08-01	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Major Pharmaceuticals	1b591e27-b00b-41c8-9fe9-c633aba09134	2025-08-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	377248b6-d64d-8dff-e063-6394a90a43f6	2025-07-31	Warnings	Exact identifier application number: M012
meijer Daytime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Meijer, Inc.	3771f778-7ac9-7108-e063-6394a90a1105	2025-07-31	Warnings	Exact identifier application number: M012
tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca	2025-07-31	Warnings	Exact identifier application number: M012
Equate Nasal	OXYMETAZOLINE HCL	Wal-Mart Stores Inc	c38a2783-aed9-466d-8976-59d03a792c04	2025-07-30	Warnings	Exact identifier application number: M012
Quality Choice Throat Soothing Drops Creamy Strawberry	PECTIN	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3b15d2ea-f784-275d-e063-6394a90a800c	2025-07-29	Warnings	Exact identifier application number: M012
Respiratory Relief	GUAIFENESIN	Schwabe North America, Inc	f683041a-4ff9-42a5-9047-a9a3140a8758	2025-07-29	Warnings	Exact identifier application number: M012
Childrens Robitussin Honey Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	b87f700e-3414-463c-80d4-c3dbca89a488	2025-07-29	Warnings	Exact identifier application number: M012
Tussin DM	TUSSIN DM	Allegiant Health	7a2f8d48-3123-4c37-b238-bd7cc4242bb7	2025-07-23	Warnings	Exact identifier application number: M012
Dr. SANA COUGH AND CHEST CONGESTION DM SUGAR FREE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	5fb2438b-8f2d-4af2-9981-42d278d26800	2025-07-23	Warnings	Exact identifier application number: M012
DR. SANA COUGH AND CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GADAL Laboratories, Inc	baca0580-4c30-4b94-89fa-a7cf06d4ff25	2025-07-22	Warnings	Exact identifier application number: M012
Defensol D	ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI	Menper Distributors, Inc.	f466c660-69eb-4581-81ff-1499fa421d8b	2025-07-22	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