Sinus Relief Severe Congestion

Product NDC: 52904-455
11-digit product format: 529040455
Labeler code: 52904
Product ID: 52904-455_2e8b8f3d-80be-4a9f-abf1-4ae5bc0e5f23
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen,Guaifenesin, Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Select Corporation
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-10-15
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active strength: 325 mg/1; mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	52904-455		I	Inactivated by FDA		2026-10-05
excluded package	package	52904-455	52904-455-50	I	Inactivated by FDA		2026-10-05

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52904-455-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52904-455-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52904-455-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52904-455-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52904-455-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52904-455-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52904-455-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52904-455-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52904-455-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52904-455-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52904-455-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52904-455-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52904-455-50	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52904-455-50	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52904-455-50	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52904-455-50	2023-01-30	C162847	48780-1	f386c64a-3ba2-0266-e053-dadaa90a7c1a	9196d2e1-c3ef-4b46-b10b-bbab08229cbb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52904-455-02	Sinus Relief Severe Congestion	2 in 1 PACKET	TABLET	2	2
52904-455-06	Sinus Relief Severe Congestion	1 in 1 CARTON	TABLET	1	2
52904-455-50	Sinus Relief Severe Congestion	25 in 1 BOX	TABLET	25	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52904-455	SINUS RELIEF SEVERE CONGESTION (ACETAMINOPHEN,GUAIFENESIN, PHENYLEPHRINE HCL) TABLET [SELECT CORPORATION]	2	Legacy NDC, 3 package rows	20180210_9196d2e1-c3ef-4b46-b10b-bbab08229cbb.zip

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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1243679	acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	9196d2e1-c3ef-4b46-b10b-bbab08229cbb	2
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	9196d2e1-c3ef-4b46-b10b-bbab08229cbb	2
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	9196d2e1-c3ef-4b46-b10b-bbab08229cbb	2
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	9196d2e1-c3ef-4b46-b10b-bbab08229cbb	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52904-455-02	52904045502	2 in 1 PACKET						Historical
52904-455-06	52904045506	1 in 1 CARTON						Historical
52904-455-50	52904045550	25 CARTON in 1 BOX (52904-455-50) > 1 PACKET in 1 CARTON (52904-455-06) > 2 TABLET in 1 PACKET (52904-455-02)	25 carton	2012-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ACETAMINOPHEN - Select Corporation \| ULTRAtab Laboratories, Inc.	Select Corporation \| ULTRAtab Laboratories, Inc.	2012-10-15	HUMAN OTC DRUG LABEL	2