TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT

Product NDC: 50580-131
11-digit product format: 505800131
Labeler code: 50580
Product ID: 50580-131_572ebe9a-09d7-46c2-e063-6394a90a26b5
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-09-25
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
Active strength: 15; 6.25; 325 mg/1; mg/1; mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/1
DOXYLAMINE SUCCINATE	6.25 mg/1
ACETAMINOPHEN	325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094549	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
1c5386c1-e45d-9dcb-e063-6294a90aff07	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
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
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
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
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
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
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-131-24	TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		3
50580-131-24	TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-131	TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC]	3	Current NDC, 2 package rows	20241215_1c5386c1-e45d-9dcb-e063-6294a90aff07.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 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique Medi-Mucus	DEXTROMETHORPHAN HBR, GUAIFENESIN	Unifirst First Aid Corporation	f3bb862a-9cb8-f644-e053-2a95a90a5f4f	2025-09-08	Warnings	Exact identifier application number: M012
Physicians Care Cough and Sore Throat	MENTHOL	Acme United Corporation	4e02223d-f34b-333e-e054-00144ff8d46c	2025-09-08	Warnings	Exact identifier application number: M012
Physicians Care Non-Drowsy Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Acme United	186ec543-1f23-75d6-e063-6294a90a46b9	2025-09-08	Warnings	Exact identifier application number: M012
PhysiciansCare Sinus Non-Drowsy	PHENYLEPHRINE HCL	Acme United Corporation	a6daf3ef-f386-4de4-b38e-d0b90c9ae62b	2025-09-08	Warnings	Exact identifier application number: M012
PhysiciansCare Allergy Multi-Symptom Relief	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	Acme United Corporation	fd101c27-6ba9-4cd3-baec-a354504c37a0	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Honey Lemon Cough Drop	MENTHOL 8.6 MG	Unifirst First Aid Corporation	8a94f090-61d6-4909-e053-2995a90aee38	2025-09-08	Warnings	Exact identifier application number: M012
Green Guard Cough Drop Relief	MENTHOL	Unifirst First Aid Corporation	0fc4cb11-8ff9-4eff-9588-c73eef4e0137	2025-09-08	Warnings	Exact identifier application number: M012
Multi-Symptom Cold Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , GUAIFENESIN, ,	Unifirst First Aid Corporation	e6ea6faf-baff-a130-e053-2a95a90a085a	2025-09-08	Warnings	Exact identifier application number: M012
MEDIQUE Medikoff Drops	MENTHOL	Unifirst First Aid Corporation	0d6b4443-16a1-4851-bb03-d7407167551d	2025-09-08	Warnings	Exact identifier application number: M012
Medique Sugar Free Medikoff Drops	MENTHOL	Unifirst First Aid Corporation	92d13e19-4e7b-4565-970e-504abf02579a	2025-09-08	Warnings	Exact identifier application number: M012
Medique at Home Diphen	DIPHENHYDRAMINE HCL	Unifirst First Aid Corporation	b56d1966-efd7-56eb-e053-2995a90a89b5	2025-09-08	Warnings	Exact identifier application number: M012
Medique Chlorphen	CHLORPHENIRAMINE MALEATE	Unifirst First Aid Corporation	b3d5d161-8d4c-f1bb-e053-2a95a90a5bc5	2025-09-08	Warnings	Exact identifier application number: M012
Crane Safety Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Crane Safety LLC	968baa85-ce0e-0c3d-e053-2995a90ac03a	2025-09-08	Warnings	Exact identifier application number: M012
Thompson Cherry Cough Drops	MENTHOL	Thompson Safety LLC	c948f5b0-8491-6f9f-e053-2995a90a55fa	2025-09-08	Warnings	Exact identifier application number: M012
Medique Decorel Forte	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Unifirst First Aid Corporation	e64c283b-0efa-0bfd-e053-2a95a90ab71d	2025-09-08	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	Walgreens	a99fdd49-0160-4a82-983b-fa56ab38ae76	2025-09-08	Warnings	Exact identifier application number: M012
Dye Free Wal Dryl Allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	53e6f72d-15a4-4efe-8b1f-5753fed53df8	2025-09-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreens	40bfd631-51a4-4684-9ba0-a365d61da9bc	2025-09-08	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	f796ce1f-3077-4a0d-a41a-249c345ddb5f	2025-09-08	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	6ccbd537-2264-4b3c-804e-3d3ea5368a5f	2025-09-05	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2676954	{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack	GPCK	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
2676954	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	PSN	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
1867684	acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule	PSN	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	1c5386c1-e45d-9dcb-e063-6294a90aff07	3
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
1867684	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule	SCD	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	1c5386c1-e45d-9dcb-e063-6294a90aff07	3
2676954	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	SY	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
1867684	acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule	SY	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
1867684	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule	SY	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	1c5578e6-7e67-c467-e063-6294a90a6e0b	3
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	1c5386c1-e45d-9dcb-e063-6294a90aff07	3
2676954	{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack	GPCK	48f7933e-6582-638c-e063-6394a90abfe5	1
2676954	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	PSN	48f7933e-6582-638c-e063-6394a90abfe5	1
1867684	acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule	PSN	48f7933e-6582-638c-e063-6394a90abfe5	1
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	48f7933e-6582-638c-e063-6394a90abfe5	1
1867684	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule	SCD	48f7933e-6582-638c-e063-6394a90abfe5	1
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	48f7933e-6582-638c-e063-6394a90abfe5	1
2676954	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	SY	48f7933e-6582-638c-e063-6394a90abfe5	1
1867684	acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule	SY	48f7933e-6582-638c-e063-6394a90abfe5	1
1867684	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule	SY	48f7933e-6582-638c-e063-6394a90abfe5	1
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	48f7933e-6582-638c-e063-6394a90abfe5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50580-131-24	50580013124	2 BLISTER PACK in 1 CARTON (50580-131-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2024-09-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS DAY + NIGHT	Kenvue Brands LLC	2026-08-12	HUMAN OTC DRUG LABEL	5
TYLENOL® COLD + FLU MULTI-SYMPTOM LIQUID GELS NIGHT	Kenvue Brands LLC	2026-07-22	HUMAN OTC DRUG LABEL	4
TYLENOL® Cold + Flu Multi-Symptom Liquid Gels Day + Night	Kenvue Brands LLC	2026-02-06	HUMAN OTC DRUG LABEL	1