Severe Sinus Pain and Congestion

Product NDC: 59779-275
11-digit product format: 597790275
Labeler code: 59779
Product ID: 59779-275_8505a29b-8fe3-49eb-870c-f076b4c4826f
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, guaifenesin, phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: CVS Pharmacy
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-08-06
Marketing end: 2028-04-30
Substance: ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 200; 5 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
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: Severe Sinus Pain and Congestion
Brand name suffix: Daytime

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
GUAIFENESIN	200 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
495W7451VQ	Internal UNII lookup
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
1243679	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
4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7	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
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
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
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	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	Strength	SPL version
59779-275-08	Severe Sinus Pain and CongestionDaytime	2 in 1 CARTON	TABLET, FILM COATED	2		15
59779-275-08	Severe Sinus Pain and CongestionDaytime	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-275-08	EA - Each	59779-275	ef56c562-5764-4932-ab6a-0bb0681ac4ac	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WOONSOCKET PRESCRIPTION CENTER,INCORPORATED]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-275	SEVERE SINUS PAIN AND CONGESTION DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [CVS PHARMACY]	14	Current NDC, Legacy NDC, 2 package rows	20250105_4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7.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 86 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreen NightTime Cold and Flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREENS CO.	6b3766e6-d0d4-49e0-90da-fc893aef3329	2025-11-25	Warnings	Exact identifier application number: M012
Adult Allergy Relief Dye Free	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	586310f3-0014-4cfc-9d86-961b3fb7aa8c	2025-11-25	Warnings	Exact identifier application number: M012
childrens Allergy Dye Free Wal Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN CO.	4e64e040-1662-4dc9-b33f-3e119e0b3f7b	2025-11-25	Warnings	Exact identifier application number: M012
Walgreen	NASAL	WALGREENS CO	d38f8406-d7b9-472c-a472-58968bbdb993	2025-11-25	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	780907b8-34ba-4ec8-bcdf-b2a31bd111df	2025-11-25	Warnings	Exact identifier application number: M012
Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	d13efbcd-1277-45d0-8389-1ba0337f7a24	2025-11-25	Warnings	Exact identifier application number: M012
Childrens Robitussin Elderberry Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	fe903448-b422-42e0-b05b-aeb3e5481e3c	2025-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	1d4fcb76-22d1-7292-e063-6394a90af920	2025-11-25	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGH Soft CHEWS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	f22248b7-7abd-4df7-a986-dae357ebe8f1	2025-11-25	Warnings	Exact identifier application number: M012
ROBITUSSIN Nighttime Cough DM Soft CHEWS	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	39468746-e06d-4849-9d06-9af4d14351b0	2025-11-25	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Grocery Outlet, Inc.	4478fd51-bae3-6108-e063-6394a90a07ca	2025-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC.	395bb39a-e26f-f4f2-e063-6394a90ae721	2025-11-25	Warnings	Exact identifier application number: M012
day time	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	eaf3af6a-de5b-43fe-83ff-9641646e0f6b	2025-11-25	Warnings	Exact identifier application number: M012
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	RB Health (US) LLC	38571853-992f-9998-e063-6394a90a8581	2025-11-24	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	e19b561c-fb76-4355-a306-d3dc46930bf2	2025-11-24	Warnings	Exact identifier application number: M012
Sinus Decongestion	PSEUDOEPHEDRINE HCL	Kroger Company	73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c	2025-11-24	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Cardinal Health (Leader) 70000	14c507df-fbac-4a09-a66c-b91c2abbf550	2025-11-24	Warnings	Exact identifier application number: M012
Severe Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI	Family Dollar (FAMILY WELLNESS)	e5c90d6e-70aa-4886-bc81-293e0dcf5638	2025-11-24	Warnings	Exact identifier application number: M012
Throat Coat Eucalyptus Mint	MENTHOL	Traditional Medicinals, Inc.	a7a86f1b-30e8-6f5d-e053-2a95a90a2a82	2025-11-21	Warnings	Exact identifier application number: M012
Throat Coat Sweet Orange Fennel	MENTHOL	Traditional Medicinals, Inc.	4538248f-11cc-d6b2-e063-6294a90a652c	2025-11-21	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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

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	4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7	15
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7	15
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7	15
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	4af347ce-9745-4a5e-8ce9-e7c97a0a6cc7	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-275-08	59779027508	2 BLISTER PACK in 1 CARTON (59779-275-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2005-08-06	2028-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS 44-527C-SC Delisted	CVS Pharmacy \| LNK International, Inc.	2026-01-02	HUMAN OTC DRUG LABEL	15