Nighttime Cold and Cough

Product NDC: 82673-191
11-digit product format: 826730191
Labeler code: 82673
Product ID: 82673-191_dc74d4ef-7829-48a9-ae25-76fb92f1141c
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: KinderFarms, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-05-30
Marketing end: 2027-12-28
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 12.5 mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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: Nighttime Cold and Cough

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	12.5 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82673-191-04	Nighttime Cold and Cough	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		5
82673-191-04	Nighttime Cold and Cough	1 in 1 BOX	LIQUID	1		5
82673-191-04	Daytime Cough Congestion Nighttime Cold Cough	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118 mL	12.5 mg in 5mL	3
82673-191-04	Daytime Cough Congestion Nighttime Cold Cough	1 in 1 BOX	LIQUID		12.5 mg in 5mL	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82673-191	NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HCL) LIQUID [KINDERFARMS, LLC]	5	Current NDC, 2 package rows	20241003_bfcedca7-f758-4654-822a-5c431906f34d.zip
82673-191	DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL) KIT [KINDERFARMS, LLC]	3	Current NDC	20240913_f2113abf-c1a3-42a6-a25e-e30a31fcad95.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 99 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Freegells Cough Drops Menthol Honey Lemon 80ct	MENTHOL	R.L. ALBERT & SON, INC	61deea94-d0a9-4563-926b-53f255a7c425	2025-10-08	Warnings	Exact identifier application number: M012
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPS	MENTHOL	R.L. ALBERT & SON, INC	c6b36350-386b-4346-bef0-a37ec11319c0	2025-10-08	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	3314b174-d5bb-4843-9288-9b9c5fce79d5	2025-10-08	Warnings	Exact identifier application number: M012
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral Solution	DIPHENHYDRAMINE HCL	MEDWISE LIFESCIENCES INC.	407b7cbb-7ebd-7b7e-e063-6394a90af501	2025-10-06	Warnings	Exact identifier application number: M012
Quality Choice Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc	2025-10-06	Warnings	Exact identifier application number: M012
Halls Sugar Free Honey Lemon	MENTHOL	Mondelez Global LLC	2b19fdd2-8088-47f2-be20-f220a6b825fc	2025-10-06	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories, Inc	40802fb6-c1ec-d7b0-e063-6394a90ab423	2025-10-06	Warnings	Exact identifier application number: M012
Giltuss Diabetic	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dextrum Laboratories, Inc	3f64c81a-bbfc-4575-e063-6294a90a6ed7	2025-10-06	Warnings	Exact identifier application number: M012
TexaClear Severe Cough, Cold and Flu	CHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	GM Pharmaceuticals, INC	cb99e5b3-1908-43c9-b31f-d35e7ce58b44	2025-10-06	Warnings	Exact identifier application number: M012
RoboHBr Cough SUPPRESSANT	DEXTROMETHORPHAN HBR	DXM Pharmaceutical, Inc	0af624ce-191f-45e1-882b-e8acb90cc77b	2025-10-06	Warnings	Exact identifier application number: M012
RoboTablets	DEXTROMETHORPHAN	DXM Pharmaceutical, Inc	b92cf698-032d-4d8d-b19c-456c6338b094	2025-10-06	Warnings	Exact identifier application number: M012
SinuLief	LORATADINE	RoseWell Pharmaceuticals LLC	32619143-a782-3497-e063-6394a90aaaec	2025-10-06	Warnings	Exact identifier application number: M012
STAHIST AD	CHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	Magna Pharmaceuticals, Inc.	ccedbc38-2479-4c35-9f86-a9f29bcfab3f	2025-10-03	Warnings	Exact identifier application number: M012
Childrens PediaClear 8	PYRILAMINE MALEATE	GM Pharmaceuticals, INC	8e524967-d01c-4c93-9198-c42f15fe3fe0	2025-10-03	Warnings	Exact identifier application number: M012
Childrens PediaClear PD	TRIPROLIDINE HYDROCHLORIDE	GM Pharmaceuticals, INC	f3ede5b7-1b0f-493a-b647-4459affc7e54	2025-10-03	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	InvaTech Pharma Solutions LLC	40288ecf-043d-eb9e-e063-6394a90ac0a7	2025-10-02	Warnings	Exact identifier application number: M012
Guaifenesin 400	GUAIFENESIN TABLETS 400	InvaTech Pharma Solutions LLC	40291505-55ca-0759-e063-6394a90acee1	2025-10-02		Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3dd5b783-5b64-24b5-e063-6394a90ab4ee	2025-10-02	Warnings	Exact identifier application number: M012
Acetaminophen and Diphenhydramine citrate	ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE	InvaTech Pharma Solutions LLC	403a88fa-e06b-9b6e-e063-6394a90a97b8	2025-10-02	Warnings	Exact identifier application number: M012
Equaline childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	United Natural Foods, Inc. dba UNFI	3053f6d7-0eff-488c-8901-770dcc62af06	2025-10-02	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	bfcedca7-f758-4654-822a-5c431906f34d	5
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	bfcedca7-f758-4654-822a-5c431906f34d	5
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	bfcedca7-f758-4654-822a-5c431906f34d	5
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	bfcedca7-f758-4654-822a-5c431906f34d	5
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	bfcedca7-f758-4654-822a-5c431906f34d	5
2683226	{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 2.5 MG/ML Oral Solution) } Pack	GPCK	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
2683226	1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE hydrochloride 12.5 MG in 5 mL Oral Solution) Pack	PSN	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
1049906	diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution	PSN	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
1049906	diphenhydramine hydrochloride 2.5 MG/ML Oral Solution	SCD	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
2683226	1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydramine hydrochloride 12.5 MG per 5 ML Oral Solution) Pack	SY	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
1049906	diphenhydramine HCl 12.5 MG per 5 ML Oral Solution	SY	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
1049906	diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution	SY	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3
1049906	diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution	SY	f2113abf-c1a3-42a6-a25e-e30a31fcad95	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
82673-191-04	82673019104	1 BOTTLE, PLASTIC in 1 BOX (82673-191-04) / 118 mL in 1 BOTTLE, PLASTIC	2024-05-30	2027-12-28	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	KinderFarms, LLC	2026-09-28	HUMAN OTC DRUG LABEL	6
Drug Facts	KinderFarms, LLC	2024-09-12	HUMAN OTC DRUG LABEL	3