Tukol Honey Nighttime Cold and Flu

Product NDC: 50066-303
11-digit product format: 500660303
Labeler code: 50066
Product ID: 50066-303_24fec102-30d8-373f-e063-6394a90ac8ab
Type: HUMAN OTC DRUG
Nonproprietary name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, and DOXYLAMINE SUCCINATE
Dosage form: SYRUP
Route: ORAL
Labeler: Genomma Lab USA
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-02-09
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 21.667; 1; .4167 mg/mL; mg/mL; mg/mL
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: 2026-12-31
Current FDA listing: Yes

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 · 6 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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50066-303-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50066-303-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50066-303-04	`bd6a592717d7…`	`303034d00443…`

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: Tukol Honey Nighttime Cold and Flu
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	21.667 mg/mL
DEXTROMETHORPHAN HYDROBROMIDE	1 mg/mL
DOXYLAMINE SUCCINATE	.4167 mg/mL

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
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043400	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
bf25f38e-3549-4f78-be90-46605b5f2c11	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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
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
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-01-11	Tukol ® Honey Nighttime Cold & Flu
2023-07-28	Tukol ® Honey Nighttime Cold & Flu
2023-01-20	Tukol ® Honey Nighttime Cold & Flu
2022-01-28	Tukol ® Honey Nighttime Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50066-303-04	Tukol Honey Nighttime Cold and Flu	1 in 1 CARTON	SYRUP	1		9
50066-303-04	Tukol Honey Nighttime Cold and Flu	118 mL in 1 BOTTLE, PLASTIC	SYRUP	118		9
50066-303-04	Tukol Honey Daytime and Nighttime Value Pack	118 mL in 1 BOTTLE, PLASTIC	SYRUP	118 mL	0.4167 mg in 1mL	8
50066-303-04	Tukol Honey Daytime and Nighttime Value Pack	1 in 1 CARTON	SYRUP		21.667 mg in 1mL	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50066-303	TUKOL HONEY NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) SYRUP [GENOMMA LAB USA]	9	Current NDC, Legacy NDC, 2 package rows	20241023_bf25f38e-3549-4f78-be90-46605b5f2c11.zip
50066-303	TUKOL HONEY DAYTIME AND NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE) KIT [GENOMMA LAB USA]	8	Current NDC, Legacy NDC	20241024_bccc11d2-d227-4cbb-b0fc-ac6abb6dce57.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 67 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PHARBINEX-DM	GUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MG	Pharbest Pharmaceuticals, Inc.	8d71db43-da87-45ee-aa4a-7e870bc5016d	2025-12-24	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway, Inc.	764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be	2025-12-23	Warnings	Exact identifier application number: M012
Tussin	GUAIFENESIN	Discount Drug Mart	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	2025-12-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	c8dcba06-a461-4af5-a120-666a63f06ac4	2025-12-23	Warnings	Exact identifier application number: M012
SAFETUSSIN MAX STRENGTH MS Cough, Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	920bde5f-4079-45de-aa59-24b00e50cb56	2025-12-23	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	46996bbf-948c-0aba-e063-6394a90a09e3	2025-12-23	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc.	1d2e2a5a-099b-41b3-82bd-5bf704377f78	2025-12-23	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	5b493ed7-9044-4841-9935-236d0bdc71a9	2025-12-23	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	77a7ff9a-a414-4053-8d8d-369907d4380d	2025-12-23	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc.	8f320235-f243-4211-b99c-18526e686548	2025-12-23	Warnings	Exact identifier application number: M012
Circle K Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	b6a46498-d9a8-4da2-9283-57d135f305a5	2025-12-23	Warnings	Exact identifier application number: M012
Circle K Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc.	7c5faec2-28c6-4c15-a268-d8b578140b74	2025-12-23	Warnings	Exact identifier application number: M012
Sugar Free Honey Lemon Cough Drops	MENTHOL	Walmart	67650b94-adbb-87fb-e053-2a91aa0a87e6	2025-12-23	Warnings	Exact identifier application number: M012
Equate Benz-Dex Cough and Throat Lozenges	BENZOCAINE	Walmart	c0a6cb7f-a247-e610-e053-2a95a90a4199	2025-12-23	Warnings	Exact identifier application number: M012
Equate Honey Lemon Cough Drops	MENTHOL	WalMart	0028be18-5162-ff51-e063-6294a90ae517	2025-12-23	Warnings	Exact identifier application number: M012
Equate SF Menthol Cough Drops	MENTHOL	WalMart	003a229c-b014-e9f3-e063-6294a90aa5ed	2025-12-23	Warnings	Exact identifier application number: M012
Equate Menthol Cough Drops	MENTHOL	Walmart	124e6968-f59c-39d4-e063-6294a90a66d4	2025-12-23	Warnings	Exact identifier application number: M012
Equate Severe Menthol Throat Drop	MENTHOL	Walmart	125f3f5a-52aa-e398-e063-6394a90a0012	2025-12-23	Warnings	Exact identifier application number: M012
Equate Menthol Chewable Gels	MENTHOL	Walmart	1ba4b2be-7242-0a23-e063-6294a90af29c	2025-12-23	Warnings	Exact identifier application number: M012
Walgreens Severe Menthol Throat Drops	MENTHOL	Walgreens	21dd3c68-cbc6-4799-e063-6394a90a6972	2025-12-23	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
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	bf25f38e-3549-4f78-be90-46605b5f2c11	9
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	bf25f38e-3549-4f78-be90-46605b5f2c11	9
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	bf25f38e-3549-4f78-be90-46605b5f2c11	9
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	bf25f38e-3549-4f78-be90-46605b5f2c11	9
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	bf25f38e-3549-4f78-be90-46605b5f2c11	9
2637726	{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack	GPCK	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
2637726	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack	PSN	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
2637726	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack	SY	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	bccc11d2-d227-4cbb-b0fc-ac6abb6dce57	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50066-303-04	50066030304	1 BOTTLE, PLASTIC in 1 CARTON (50066-303-04) / 118 mL in 1 BOTTLE, PLASTIC	2020-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tukol ® Honey Daytime & Nighttime Value Pack	Genomma Lab USA	2024-10-22	HUMAN OTC DRUG LABEL	8
Tukol ® Honey Nighttime Cold & Flu	Genomma Lab USA	2024-10-21	HUMAN OTC DRUG LABEL	9