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
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82673-191-04Nighttime Cold and Cough118 mL in 1 BOTTLE, PLASTICLIQUID1185
82673-191-04Nighttime Cold and Cough1 in 1 BOXLIQUID15
82673-191-04Daytime Cough Congestion Nighttime Cold Cough118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12.5 mg in 5mL3
82673-191-04Daytime Cough Congestion Nighttime Cold Cough1 in 1 BOXLIQUID12.5 mg in 5mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82673-191NIGHTTIME COLD AND COUGH (DIPHENHYDRAMINE HCL) LIQUID [KINDERFARMS, LLC]5Current NDC, 2 package rows20241003_bfcedca7-f758-4654-822a-5c431906f34d.zip
82673-191DAYTIME COUGH CONGESTION NIGHTTIME COLD COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL) KIT [KINDERFARMS, LLC]3Current NDC20240913_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 18 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus CongestionPHENYLEPHRINE HCLL.N.K. International, Inc.81f0276a-99a2-4a57-a0d8-224735aa8c792026-07-10WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN, PHENYLEPHRINE HCLRite Aid Corporationefaf3be1-ab39-45f7-a45c-7fea8705c8d02026-07-10WarningsExact identifier
application number: M012
Equate Daytime Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.f847d9f2-aa47-4bbe-8f06-19356c6373982026-07-10WarningsExact identifier
application number: M012
Sinus and Allergy Relief PECHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLTopco Associates, LLC2a80fba9-5e30-4ec0-bd8e-8957c0654b6c2026-07-10WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50230cad-3d04-8882-e063-6294a90acf3c2026-07-09WarningsExact identifier
application number: M012
Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLRugby Laboratoriesfc42e97d-1224-4d29-a55d-1a1885e0bf8f2026-07-09WarningsExact identifier
application number: M012
Head Congestion and MucusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader7418d92d-a540-40d6-91d0-b7eb1f87f8ff2026-07-08WarningsExact identifier
application number: M012
DG HEALTH COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDolgencorp Inc5d9d57aa-e43a-4dbe-9d35-36a7b82d4e6d2026-07-08WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLTopco Associates, LLCbfcabe02-7961-4407-a748-8cd0877313982026-07-08WarningsExact identifier
application number: M012
Aller-chlorCHLORPHENIRAMINE MALEATERugby Laboratories04ca3806-72be-47d4-9fea-5b0dee0876832026-07-08WarningsExact identifier
application number: M012
nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED24c22c9f-0c2f-46dc-850e-ed05f00d3e952026-07-08WarningsExact identifier
application number: M012
NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.0e65c5d1-a18b-452c-9be6-8d44d34577e92026-07-08WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATECardinal Health 110, LLC. DBA Leaderaaecfda5-1a50-4d8a-9909-7153c1a22bda2026-07-08WarningsExact identifier
application number: M012
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7cb9f378-5d64-475f-bf26-4058ba6c15b42026-07-08WarningsExact identifier
application number: M012
DG HEALTH DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEDolgencorp Incf174d08e-3335-4cc9-8766-4070f18c4f312026-07-08WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESIN 400 MGHealth Pharma USA LLCd60a3e9d-e88e-3b19-e053-2995a90a3e8d2026-07-07WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLCd38f47ea-7fda-170b-e053-2995a90adc822026-07-07WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINHealth Pharma USA LLCd68222f7-b796-7b27-e053-2995a90a2efe2026-07-07WarningsExact identifier
application number: M012
Cold and Flu Severe Day Time / Night TimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLCacdcc6ce-c190-4de6-b126-62fe9043112e2026-07-07WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC471b1a43-1708-8be7-e063-6394a90a9bb72026-07-06WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNbfcedca7-f758-4654-822a-5c431906f34d5
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDbfcedca7-f758-4654-822a-5c431906f34d5
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYbfcedca7-f758-4654-822a-5c431906f34d5
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYbfcedca7-f758-4654-822a-5c431906f34d5
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYbfcedca7-f758-4654-822a-5c431906f34d5
2683226{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 2.5 MG/ML Oral Solution) } PackGPCKf2113abf-c1a3-42a6-a25e-e30a31fcad953
26832261 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) PackPSNf2113abf-c1a3-42a6-a25e-e30a31fcad953
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNf2113abf-c1a3-42a6-a25e-e30a31fcad953
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNf2113abf-c1a3-42a6-a25e-e30a31fcad953
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDf2113abf-c1a3-42a6-a25e-e30a31fcad953
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDf2113abf-c1a3-42a6-a25e-e30a31fcad953
26832261 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) PackSYf2113abf-c1a3-42a6-a25e-e30a31fcad953
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYf2113abf-c1a3-42a6-a25e-e30a31fcad953
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYf2113abf-c1a3-42a6-a25e-e30a31fcad953
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYf2113abf-c1a3-42a6-a25e-e30a31fcad953
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYf2113abf-c1a3-42a6-a25e-e30a31fcad953
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYf2113abf-c1a3-42a6-a25e-e30a31fcad953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82673-191-04826730191041 BOTTLE, PLASTIC in 1 BOX (82673-191-04) / 118 mL in 1 BOTTLE, PLASTIC2024-05-302027-12-28NoNoHistorical