FDA.reportPublic FDA data

Childrens Cold and Allergy Relief

Product NDC
70677-0101
11-digit product format
706770101
Labeler code
70677
Product ID
70677-0101_73e310bf-4f17-40a6-8d62-d71066b853b2
Type
HUMAN OTC DRUG
Nonproprietary name
Brompheniramine maleate, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-31
Marketing end
2026-12-28
Substance
BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
2; 5 mg/10mL; mg/10mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [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
Childrens Cold and Allergy Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BROMPHENIRAMINE MALEATE2 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
IXA7C9ZN03Internal 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
1053258Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d64fe757-9948-4727-b5dd-1f8e4e4763e2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-0101-1Childrens Cold and Allergy Relief1 in 1 BOXLIQUID13
70677-0101-1Childrens Cold and Allergy Relief118 mL in 1 BOTTLE, PLASTICLIQUID1183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0101-1ML - Milliliter70677-01013a05e8df-80ac-4a00-88e0-7d947dc6d62b12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0101CHILDRENS COLD AND ALLERGY RELIEF (BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) LIQUID [STRATEGIC SOURCING SERVICES LLC]3Current NDC, Legacy NDC, 2 package rows20240601_d64fe757-9948-4727-b5dd-1f8e4e4763e2.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 178 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and AllergyPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEAllegiant Health7af63769-fa56-4f1f-a2ad-5b4c108c8e4f2019-12-12WarningsExact identifier
application number: M012
Mucus Relief Immediate ReleaseGUAIFENESINAllegiant Health221d64a2-b8c7-435a-aae4-fb58fd38108f2019-03-26WarningsExact identifier
application number: M012
Sleep Tabs For Nighttime useDIPHENHYDRAMINE HCL TABLETSAllegiant Health566e40b1-e9d7-44e4-b971-eef2b7cf0a7d2018-12-26WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEAllegiant Health4305ad50-d2a5-4d3e-9d92-cbf26e856a162018-12-26WarningsExact identifier
application number: M012
Sleep AidDIPHENHYDRAMINE HCL 25 MGAllegiant Healthdbbc535f-515a-4d9b-b799-34e60f5230bb2018-12-21WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLAllegiant Healthc2823bad-540f-4662-8dcc-58e9f0d94efb2018-11-07WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum Strength Non-DrowsyPHENYLEPHRINE 10 MGAllegiant Health7aef00df-816a-4ea2-a2ad-beed66dd2fe42018-11-07WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWestminster Pharmaceuticals, LLCa58bfb14-28f9-4425-a5a5-aaff4847c9792018-03-14WarningsExact identifier
application number: M012
Chlorpheniramine maleate 4mgCHLORPHENIRAMINE MALEATE 4MGAthlete's Needs, Inc.4d974959-25fc-4707-9b72-9afbf47b76f12017-11-14WarningsExact identifier
application number: M012
Cold MedicineACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLSelder, S.A. de C.V.d2762d9c-e7e7-42b2-a26a-14b2aa0307cb2017-01-25WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMarc Glassman, Inc.2051247f-ce64-4cf5-b449-9ca14c43ab862016-12-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNd64fe757-9948-4727-b5dd-1f8e4e4763e23
1053258brompheniramine maleate 0.2 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDd64fe757-9948-4727-b5dd-1f8e4e4763e23
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral ElixirSYd64fe757-9948-4727-b5dd-1f8e4e4763e23
1053258brompheniramine maleate 1 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SolutionSYd64fe757-9948-4727-b5dd-1f8e4e4763e23
1053258brompheniramine maleate 2 MG / phenylephrine HCl 5 MG per 10 ML Oral SolutionSYd64fe757-9948-4727-b5dd-1f8e4e4763e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70677-0101-1706770101011 BOTTLE, PLASTIC in 1 BOX (70677-0101-1) / 118 mL in 1 BOTTLE, PLASTIC2020-01-312026-12-28NoNoCurrent