Tylenol Sinus Severe

Product NDC: 50580-507
11-digit product format: 505800507
Labeler code: 50580
Product ID: 50580-507_5e691fd8-3462-c044-e063-6294a90ad886
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-05-15
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
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: Tylenol Sinus Severe
Listing expiration: 2027-12-31

Active Ingredients#

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

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	SPL version
50580-507-01	Tylenol Sinus Severe	12 in 1 BLISTER PACK	TABLET, COATED	12	16
50580-507-01	Tylenol Sinus Severe	2 in 1 CARTON	TABLET, COATED	2	16
50580-507-02	Tylenol Sinus Severe	2 in 1 CARTON	TABLET, COATED	2	16
50580-507-02	Tylenol Sinus Severe	3 in 1 PACKAGE	TABLET, COATED	3	16
50580-507-03	Tylenol Sinus Severe	2 in 1 POUCH	TABLET, COATED	2	16
50580-507-04	Tylenol Sinus Severe	50 in 1 CARTON	TABLET, COATED	50	16
50580-507-04	Tylenol Sinus Severe	2 in 1 POUCH	TABLET, COATED	2	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-507-01	EA - Each	50580-507	ee10d929-4cd2-4906-8663-c84fe7e61be4	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Guaifenesin	ACTIVE INGREDIENT	495W7451VQ	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Phenylephrine Hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Guaifenesin	ACTIVE MOIETY	495W7451VQ	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
Phenylephrine	ACTIVE MOIETY	1WS297W6MV	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
hydroxypropyl cellulose (type e)	INACTIVE INGREDIENT	66O7AQV0RT	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-507	TYLENOL SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [KENVUE BRANDS LLC]	16	Current NDC, Legacy NDC, 7 package rows	20241103_7a60184f-91a9-4b85-b243-871deca63450.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 81 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels	ACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51dec468-fbb2-3489-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	d7711cd6-5058-548d-e053-2a95a90ac54d	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	a2f0285b-8550-fd26-e053-2995a90ab615	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	f6c73f61-f4fc-377f-e053-6294a90a3797	2025-12-04	Warnings	Exact identifier application number: M012
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Bayer Healthcare LLC.	a32e2a5e-9aa0-4e7c-e053-2995a90a3190	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e2877488-3539-cba2-e053-2995a90a6005	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cough and Sore Throat FizzyChews	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	14951faa-9476-6f29-e063-6394a90a14c7	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels	ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION	Bayer HealthCare LLC.	0c120569-622d-3a23-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Flu FizzyChews	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	149330be-24bd-b4a4-e063-6394a90a9007	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN	Bayer HealthCare LLC.	5278a128-41ec-4494-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Orange Zest	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	53188c41-3f13-311b-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	75894849-a0ba-57be-e053-2a91aa0a049a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Sparkling Original	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	531ab703-179a-70ad-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	7588ea67-68a9-4dc0-e053-2991aa0aa471	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Cough	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	75862805-2cfe-fb45-e053-2991aa0a1403	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	5172dc01-4e7f-3307-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid Gels	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	20ae92d9-fbc6-5b7a-e063-6294a90a15c3	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51c44970-06e5-082e-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	54236151-37db-0b5a-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	52542774-fd05-640c-e054-00144ff8d46c	2025-12-04	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	7a60184f-91a9-4b85-b243-871deca63450	16
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	7a60184f-91a9-4b85-b243-871deca63450	16
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	7a60184f-91a9-4b85-b243-871deca63450	16
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	7a60184f-91a9-4b85-b243-871deca63450	16
1243679	acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24	6
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24	6
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24	6
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	4bff8a41-ec6f-4bc5-a3df-2ea4695d9e24	6
1243679	acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	8eecb3f0-eb5e-e847-e053-2995a90a86bd	3
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	8eecb3f0-eb5e-e847-e053-2995a90a86bd	3
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	8eecb3f0-eb5e-e847-e053-2995a90a86bd	3
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	8eecb3f0-eb5e-e847-e053-2995a90a86bd	3
1243679	acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	435b4a2a-d6bf-ec25-e063-6294a90a3f06	1
1243679	acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	37e939c6-064b-3548-e063-6294a90a337d	1
1243679	acetaminophen 325 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	1560b3a0-fe81-4e33-b581-20b43511dba3	1
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	435b4a2a-d6bf-ec25-e063-6294a90a3f06	1
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	37e939c6-064b-3548-e063-6294a90a337d	1
1243679	acetaminophen 325 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	1560b3a0-fe81-4e33-b581-20b43511dba3	1
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	435b4a2a-d6bf-ec25-e063-6294a90a3f06	1
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	37e939c6-064b-3548-e063-6294a90a337d	1
1243679	APAP 325 MG / GG 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	1560b3a0-fe81-4e33-b581-20b43511dba3	1
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	435b4a2a-d6bf-ec25-e063-6294a90a3f06	1
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	37e939c6-064b-3548-e063-6294a90a337d	1
1243679	APAP 325 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	1560b3a0-fe81-4e33-b581-20b43511dba3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-507-01	50580050701	2 BLISTER PACK in 1 CARTON (50580-507-01) / 12 TABLET, COATED in 1 BLISTER PACK	2 blister pack	2015-05-15	0000-00-00	No	No	Current
50580-507-02	50580050702	3 CARTON in 1 PACKAGE (50580-507-02) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK	3 carton	2020-07-06		No	No	Current
50580-507-03	50580050703	2 TABLET, COATED in 1 POUCH (50580-507-03)		2017-07-17	0000-00-00	No	No	Current
50580-507-04	50580050704	50 POUCH in 1 CARTON (50580-507-04) / 2 TABLET, COATED in 1 POUCH	50 pouch	2017-07-17	0000-00-00	No	No	Current
50580-507-72	50580050772	3 CARTON in 1 CARTON (50580-507-72) / 1 BLISTER PACK in 1 CARTON / 24 TABLET, COATED in 1 BLISTER PACK	3 carton	2026-03-16		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tylenol ® Sinus Severe	Kenvue Brands LLC	2026-10-22	HUMAN OTC DRUG LABEL	18
Tylenol ® Sinus Severe	Select Consumer Group LLC \| Select Consumer Group	2026-05-27	HUMAN OTC DRUG LABEL	1
Tylenol Sinus Severe	Savings Distributors LLC	2026-05-01	HUMAN OTC DRUG LABEL	3
Tylenol Sinus Severe	JC World Bell Wholesale Co., Inc.	2026-01-06	HUMAN OTC DRUG LABEL	1
Tylenol Sinus Severe	Navajo Manufacturing Company Inc.	2025-11-11	HUMAN OTC DRUG LABEL	1
Tylenol ® Sinus Severe	Morning Star OTC	2025-06-19	HUMAN OTC DRUG LABEL	1
Tylenol Sinus Severe	JC World Bell Wholesale Co., Inc. \| Kenvue Brands LLC	2024-12-31	HUMAN OTC DRUG LABEL	6