Sinus Congestion and Pain Relief

Product NDC: 11822-0588
Requested package NDC: 11822-0588-4
11-digit product format: 118220588
Labeler code: 11822
Product ID: 11822-0588_3d0b4b4b-6631-42f5-85ae-3d706b84da6d
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Phenylephrine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Rite Aid Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-03-17
Marketing end: 2026-11-22
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
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11822-0588	11822-0588-4	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sinus Congestion and Pain Relief
Brand name suffix: Non-Drowsy, Daytime

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5	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	SPL version
11822-0588-4	Sinus Congestion and Pain ReliefNon-Drowsy, Daytime	1 in 1 CARTON	TABLET, COATED	1	27
11822-0588-4	Sinus Congestion and Pain ReliefNon-Drowsy, Daytime	2 in 1 BLISTER PACK	TABLET, COATED	2	27
11822-0588-7	Sinus Congestion and Pain ReliefNon-Drowsy, Daytime	30 in 1 BLISTER PACK	TABLET, COATED	30	27
11822-0588-7	Sinus Congestion and Pain ReliefNon-Drowsy, Daytime	1 in 1 CARTON	TABLET, COATED	1	27
11822-0588-8	Sinus Congestion and Pain ReliefNon-Drowsy, Daytime	2 in 1 CARTON	TABLET, COATED	2	27
11822-0588-8	Sinus Congestion and Pain ReliefNon-Drowsy, Daytime	12 in 1 BLISTER PACK	TABLET, COATED	12	27

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SINUS CONGESTION AND PAIN RELIEF (ACETAMINOPHEN AND PHENYLEPHRINE HCL) CAPSULE [RITE AID]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11822-0588	SINUS CONGESTION AND PAIN RELIEF NON-DROWSY, DAYTIME (ACETAMINOPHEN AND PHENYLEPHRINE HCL) TABLET, COATED [RITE AID CORPORATION]	27	Current NDC, Legacy NDC, 6 package rows	20250131_8a0a8abf-0a41-44f8-8f4f-aec68a0fa0c5.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d1115a55-35cd-4f20-8872-f42983a5ebcd	2026-07-28	Warnings	Exact identifier application number: M012
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11822-0588-4	11822058804	1 BLISTER PACK in 1 CARTON (11822-0588-4) > 2 TABLET, COATED in 1 BLISTER PACK	1 blister pack	2008-03-17	2023-03-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rite Aid 44-558-Delisted	Rite Aid Corporation \| LNK International, Inc.	2025-01-30	HUMAN OTC DRUG LABEL	27