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 104 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLD AND FLU DAYTIME-NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9fab3-890a-158d-e053-2a95a90af423	2025-09-13	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Precision Dose, Inc.	4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4	2025-09-12	Warnings	Exact identifier application number: M012
Nasal Spray, Circle K	OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION	Lil' Drug Store Products, Inc.	3ea06e88-a2c6-621b-e063-6294a90a1075	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Harris Teeter, LLC	a0090dc6-0fe5-4ab2-a2cf-6ed19892f363	2025-09-12	Warnings	Exact identifier application number: M012
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	CVS Pharmacy	ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	FSA Store Inc. (Caring Mills)	8d7bb31b-a47d-4252-a0a7-79d286179fb9	2025-09-12	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	150e5c3a-7c86-4b66-af30-a376df697401	2025-09-12	Warnings	Exact identifier application number: M012
SEVERE COUGH COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	67f8d405-a2ad-4ade-93b4-9b09a0d81d8e	2025-09-11	Warnings	Exact identifier application number: M012
equate MAXIMUM STRENGTH DAYTIME SEVERE Cold and Flu SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	3862aaa5-2281-e8f9-e063-6294a90a0f7e	2025-09-09	Warnings	Exact identifier application number: M012
McKesson Sugar Free Cough Suppressant Oral Anesthetic	MENTHOL LOZENGE	McKesson Medical-Surgical	e0dfa6ca-b311-25cb-e053-2a95a90a12cc	2025-09-09	Warnings	Exact identifier application number: M012
Medique at Home Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e648f017-9e30-df6c-e053-2995a90adcd0	2025-09-09	Warnings	Exact identifier application number: M012
Medi-First Honey Lemon Cough Drops	MENTHOL 8.6 MG	Unifirst First Aid Corporation	826e1b87-e5a9-8637-e053-2991aa0aded1	2025-09-09	Warnings	Exact identifier application number: M012
Unishield Cherry Cough	MENTHOL	Unishield	b8297bc1-44b2-3de0-e053-2995a90ad01b	2025-09-09	Warnings	Exact identifier application number: M012
McKesson Cough Supressant	MENTHOL	McKesson Medical-Surgical	db5e0490-2ed8-2d53-e053-2a95a90a98f5	2025-09-09	Warnings	Exact identifier application number: M012
Duratuss AC	CODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATE	Poly Pharmaceuticals, Inc.	3e5ed178-d5d9-b8d4-e063-6394a90a91db	2025-09-09	Warnings	Exact identifier application number: M012
Rompe Pecho CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Efficient Laboratories Inc	96c4dee1-6e66-4442-a7e3-56e874414c17	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Lil Drug Store Products	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc	57c458ed-7987-453b-ab24-bbfa6580f920	2025-09-09	Warnings	Exact identifier application number: M012
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	38637189-d1ee-9405-e063-6394a90ae8b8	2025-09-09	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	fd52d8d8-7cd1-4e92-86da-354a1d5213c2	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Advanced Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e8e5fb21-a7fd-44d1-b9c4-83e949699ca6	2025-09-08	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