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 165 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dimetapp Cough and Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Foundation Consumer Healthcare	15b0f5ff-202a-d19f-e063-6394a90af2b8	2024-04-15	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	P & L Development, LLC	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	2024-04-15	Warnings	Exact identifier application number: M012
Severe Cold and Cough Relief Daytime	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	2af496a1-6fdd-4acf-9944-8b7cdf302275	2024-04-15	Warnings	Exact identifier application number: M012
Childrens Dye Free Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	1c4d09ed-4e0f-430d-b17f-6a23f996a55d	2024-04-15	Warnings	Exact identifier application number: M012
Theraflu ExpressMax Daytime Nighttime Value Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Haleon US Holdings LLC	9736ad4c-8c2e-421f-b023-f91b72d2828b	2024-04-10	Warnings	Exact identifier application number: M012
Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	b06b64c5-dbb4-4ef5-af18-3d7d4979c02f	2024-04-10	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATE	Harris Teeter, LLC	ec603195-eb36-4b5c-bc9b-c2074205b2b2	2024-04-09	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Harris Teeter, LLC	9b0648ac-0ce3-4eaa-8977-26ae864f034d	2024-04-09	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	f147d82e-4429-4c7b-bd2b-e21a09f21c92	2024-04-09	Warnings	Exact identifier application number: M012
FLONASE Headache and Allergy Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Haleon US Holdings LLC	282c103c-3888-4a35-a5b1-d492ed6892c1	2024-04-08	Warnings	Exact identifier application number: M012
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Haleon US Holdings LLC	4908b326-e1da-44ca-8087-7e41a16c27b0	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Direct Sore Throat Pain	ACETAMINOPHEN	Haleon US Holdings LLC	1b512078-24c3-4b80-8f2c-d6824d367f25	2024-04-08	Warnings	Exact identifier application number: M012
Mucus Relief Cough Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN	H E B	9ba5ca1b-2e3c-439e-8887-c26f144b88ef	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	12ace982-bd47-49b0-ba1b-e0a29d42f1d6	2024-04-08	Warnings	Exact identifier application number: M012
Allergy Childrens	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	ab28cbc4-7a6f-46e9-8616-be78e8cb24fe	2024-04-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	bd19b1f2-d9d3-4dab-8181-605f769ab62f	2024-04-08	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	9f533092-060c-4379-9a77-ecfea8aa46e1	2024-04-08	Warnings	Exact identifier application number: M012
Robitussin Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	66360295-f364-479a-8b49-c12b21918279	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Peak Cold Multi-Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	8c0a2424-e8ac-d91c-b46d-a5ee29f91936	2024-04-06	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	e7cf7c5d-5c9a-4201-9e30-1cd616071855	2024-04-06	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