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 72 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cherry Cough DropMENTHOLSafeway Inc.4a52c0c2-8659-2819-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Signature Care Cherry Cough DropsMENTHOLSafewaya733e905-af15-d3ea-e053-2a95a90aa7c32025-12-20WarningsExact identifier
application number: M012
Signature Care Honey Lemon Cough DropsMENTHOLSafewaya742449f-c76b-2b91-e053-2a95a90ae4d22025-12-20WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINETopCo60b876e7-c642-5ce8-e053-2a91aa0abd6e2025-12-20WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLTopco Associates366cc6b1-beff-29d2-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLTopCo Associates3fef2117-7311-1e66-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLTopco Associates3ff1bf05-e407-3b67-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLTopco Associates36727f0c-d6d2-28a3-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLTopco Associates36824bee-607e-7095-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Mixed Berry Sore Throat LozengesBENZOCAINETopco Associates7a00c771-9231-e877-e053-2a91aa0ac96e2025-12-20WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGNUVICARE LLCe25b440e-f389-443f-b333-c66ad17471582025-12-19WarningsExact identifier
application number: M012
Cold and Flu severeACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCLWal-Mart Stores Inc9fca25dc-f63e-487a-8b7c-84d65ea51cb52025-12-19WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.a7d2eaee-484e-43aa-8ae3-0e050219383f2025-12-19WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLPublix66d8e5f7-9766-57f3-e053-2991aa0a7e172025-12-19WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLPublix66e89fa3-ee09-1d16-e053-2a91aa0ae17c2025-12-19WarningsExact identifier
application number: M012
Poly-Vent DMDEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.739329ae-0b62-4eab-a07d-867b5d3d61e02025-12-19WarningsExact identifier
application number: M012
Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICE89494a7c-cdbf-48f1-aaa9-2e57d4388a682025-12-19WarningsExact identifier
application number: M012
DayTime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE04f9134e-1311-4843-90db-9244b9e61e1d2025-12-19WarningsExact identifier
application number: M012
Nighttime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE029e6215-b72d-4fd0-8918-db1abcc4490a2025-12-19WarningsExact identifier
application number: M012
DayTime and Nighttime Cold/Flu Relief Softgels - Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE5f680f37-b3db-450f-b8ca-f9e31a04dc042025-12-19WarningsExact 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