FDA.reportPublic FDA data

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 148 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Cold XL3 XtraACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDESelder, S.A. de C.V.da5b31dd-becd-471a-9392-d0ee4b8f95392024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3 FORTEACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMIDWAY IMPORTING INC.58252f15-485c-3061-e053-2a91aa0a23202024-10-17WarningsExact identifier
application number: M012
Cold Medicine XL3ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDEMidway Importing, Inc.e41b9beb-e274-5c02-e053-2995a90ad0f82024-10-17WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC38e70a28-eff2-4a48-b829-8cd68e80beef2024-10-17WarningsExact identifier
application number: M012
Mucus Relief XpectGUAIFENSIN, DEXTROMETHORPHANMidway Importing Inc.c2c8bd26-bbf1-c2e6-e053-2995a90a86a72024-10-17WarningsExact identifier
application number: M012
Antiflu Des Cough and FluACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATEProductos Farmaceuticos, S.A. de C.V.dcf3897a-a793-6df7-e053-2995a90a25f82024-10-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.ec6aef90-ece1-4fe6-e053-2995a90a93102024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Cold, Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Incc8eebe64-00bf-436d-a9fc-1623401bebfa2024-10-16WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart4f42c8d2-0538-4bcd-aac0-e26103a304992024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Inc9ac3e24a-d18a-48fc-8005-55393085d57b2024-10-16WarningsExact identifier
application number: M012
Nighttime CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED45471fdd-c4cd-46ad-a932-aa37327e8a412024-10-16WarningsExact identifier
application number: M012
DG Health Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc8cb15a8d-c836-4167-bc6b-dd20a34076e82024-10-16WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLCf4497e56-c69d-4ae9-bd81-80bf2ee1b17f2024-10-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFOODHOLD U.S.A., LLC8256c1fb-683d-56ab-e053-2a91aa0ac1972024-10-15WarningsExact identifier
application number: M012
SINUS SEVREACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f9586e3-a8b4-4060-e053-2995a90aa0682024-10-15WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95715f-63dc-6086-e053-2a95a90adb0c2024-10-15WarningsExact identifier
application number: M012
Allergy MultiSymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.a61636e9-8fe2-8419-e053-2a95a90a011c2024-10-15WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95b2e8-dea4-ef59-e053-2a95a90a0bcb2024-10-15WarningsExact identifier
application number: M012
Cold Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Companyd2dcbc7c-e66c-4922-83df-c706a37bf3342024-10-15WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC. (9f958d97-8dcf-332d-e053-2995a90a0a652024-10-15WarningsExact 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