FDA.reportPublic FDA data

Childrens Cold and Cough

Product NDC
21130-379
11-digit product format
211300379
Labeler code
21130
Product ID
21130-379_699a52c6-053a-43f9-b7fc-d719aead253d
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Safeway, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
6.25; 2.5 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Childrens Cold and Cough
Brand name suffix
Nighttime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE6.25 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1236048Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cbbec807-f882-4c6a-b1cd-c7fd5ce70cadAvailable on FDA.report

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
21130-379-04Childrens Cold and CoughNighttime118 mL in 1 BOTTLE, PLASTICLIQUID1187
21130-379-04Childrens Cold and CoughNighttime1 in 1 BOXLIQUID17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-379CHILDRENS COLD AND COUGH NIGHTTIME (DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [SAFEWAY, INC.]7Current NDC, Legacy NDC, 2 package rows20240517_cbbec807-f882-4c6a-b1cd-c7fd5ce70cad.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 107 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERite Aid Corporation5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a02025-08-18WarningsExact identifier
application number: M012
MAJOR NASAL DECONGESTANTOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutions4b78b9af-0975-43f8-8b44-daddef0478be2025-08-15WarningsExact identifier
application number: M012
Dr Simi Mucus Relief ExpectorantGUAIFENESINFarmacias De Similares TX LLC3c6d0e75-a685-6020-e063-6294a90a5c1b2025-08-15WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation25bf4390-23f7-4bb6-b86e-c40eaf8d92da2025-08-15WarningsExact identifier
application number: M012
Childrens Chewable Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2cac72be-4830-ad49-e063-6394a90a78322025-08-14WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTHDEXTROMETHORPHAN HBR AND GUAIFENESINAMERISOURCE BERGEN2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e2025-08-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalmart Inc.16fae164-28db-8ef1-e063-6294a90ab5da2025-08-12WarningsExact identifier
application number: M012
Exchange Select Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fbece335-a7e5-4732-a086-561b237415792025-08-12WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.779ddb89-b6e2-4bfb-bcb5-8c7ec916675a2025-08-12WarningsExact identifier
application number: M012
Equaline NasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFId7fa1720-eac4-4e82-9401-77215ce4f5452025-08-12WarningsExact identifier
application number: M012
Diabetic Tussin DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINMEDTECH PRODUCTS INCa10a3b33-7503-4334-8ed7-2bb881df43272025-08-08WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health, Inc26a55d74-f772-5d17-e063-6394a90a55832025-08-07WarningsExact identifier
application number: M012
Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bb7434978-44a8-4c51-979d-0bc446461e432025-08-06WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacyfc1e224c-5c57-43fc-ae6e-36aa0a4ae4392025-08-06WarningsExact identifier
application number: M012
childrens cold cough dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPublix Super Markets Inc6efe7097-2a99-4654-9d94-b47f2e64d19d2025-08-05WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINChain Drug Marketing Association, Inc.3b7548ee-7cd3-62c3-e063-6294a90a06122025-08-03WarningsExact identifier
application number: M012
Vaporizing chest rubCAMPHOR, EUCALYPTUS OIL, MENTHOLLJ Pharma065bb666-e482-4e96-ac75-c6577dcc5b482025-08-01WarningsExact identifier
application number: M012
Nighttime Cough-KidsCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGenexa024bb864-4214-1d8b-e063-6394a90aa5732025-08-01WarningsExact identifier
application number: M012
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRPharmadel LLC3b53e5fc-f258-c2b9-e063-6394a90ab5002025-08-01WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals1b591e27-b00b-41c8-9fe9-c633aba091342025-08-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1236048diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNcbbec807-f882-4c6a-b1cd-c7fd5ce70cad7
1236048diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDcbbec807-f882-4c6a-b1cd-c7fd5ce70cad7
1236048diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYcbbec807-f882-4c6a-b1cd-c7fd5ce70cad7
1236048diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYcbbec807-f882-4c6a-b1cd-c7fd5ce70cad7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-379-04211300379041 BOTTLE, PLASTIC in 1 BOX (21130-379-04) / 118 mL in 1 BOTTLE, PLASTIC2015-12-310000-00-00NoNoCurrent