FDA.reportPublic FDA data

Foster and Thrive Childrens Allergy Relief

Product NDC
70677-1012
11-digit product format
706771012
Labeler code
70677
Product ID
70677-1012_9a6180bd-d63f-4b21-b18e-2876ec46c334
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-12
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
Listing certified through
2026-12-31
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
Foster and Thrive Childrens Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049906Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7eaba464-5cdb-4bd4-b272-38fa108658d5Available 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
70677-1012-1Foster and Thrive Childrens Allergy Relief118 mL in 1 BOTTLELIQUID1182
70677-1012-1Foster and Thrive Childrens Allergy Relief1 in 1 CARTONLIQUID12
70677-1012-2Foster and Thrive Childrens Allergy Relief236 mL in 1 BOTTLELIQUID2362
70677-1012-2Foster and Thrive Childrens Allergy Relief1 in 1 CARTONLIQUID12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1012-1ML - Milliliter70677-1012fe420a73-e4db-487d-acf4-a017a71657e812023-08-08
70677-1012-2ML - Milliliter70677-10126dc81fa1-0027-4af2-b9b3-528eaf01c98712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1012FOSTER AND THRIVE CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HCL) LIQUID [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 4 package rows20241215_7eaba464-5cdb-4bd4-b272-38fa108658d5.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 51 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEBryant Ranch Prepack09a27aa8-e32e-4754-80b2-d5a8dd7eaa4b2026-02-17WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Ince8a48a00-3533-4c4d-94e1-8a6c6b35a7922026-02-17WarningsExact identifier
application number: M012
cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Inc1f3efcdd-4976-4aef-a7c6-a5f88d13cb782026-02-17WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHyVee Incd5bbb5e1-ff09-4563-b2c6-149ab30e06ad2026-02-17WarningsExact identifier
application number: M012
Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRChain Drug Marketing Association, Inc.3c8f34ad-589a-4872-939c-44ad5e0e47fe2026-02-17WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLValu Merchandisers Companyb6144732-99da-4be2-88e0-75f31b323d382026-02-16Warnings, Adverse reactionsExact identifier
application number: M012
topcare day time cold and flu relief multi symptom reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTopco Associates LLC6d08ca2d-6ae4-443f-9920-34b7fb46f2b42026-02-16WarningsExact identifier
application number: M012
Revasol Acetaminophen SuspensionACETAMINOPHENRnv LLC4ab6bb54-7c28-0c6b-e063-6394a90ac4a62026-02-13WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M012
Revasol Acetaminophen Suspension Dye FreeACETAMINOPHENRnv LLC4abc07b3-6a27-260f-e063-6394a90a28d62026-02-13WarningsExact identifier
application number: M012
robafen dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMajor Pharmaceuticals5e19220d-9cf3-4732-b9aa-c09db5d69ce62026-02-13WarningsExact identifier
application number: M012
Gencare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC686b9456-f16d-4b99-ae58-f607448bed8b2026-02-13WarningsExact identifier
application number: M012
nasalPHENYLEPHRINE HYDROCHLORIDEKroger Company1c3dc4e6-452b-4c84-b53c-426cf9ae8f032026-02-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFIaf42d3f7-661e-4322-aefe-2b7f9f1010d62026-02-12WarningsExact identifier
application number: M012
Childrens Giltuss DCHILDRENS GILTUSS DGil Pharmaceutical Corpcfc2493b-e99e-4b55-98a9-053f95d498442026-02-12WarningsExact identifier
application number: M012
Giltuss DGILTUSS DGil Pharmaceutical Corp298f5457-a7df-474d-9854-68918ee3d3302026-02-12WarningsExact identifier
application number: M012
VaporizingCAMPHORWalgreen Co.ef4f95c8-7650-4096-9369-ea8393781bee2026-02-12Warnings, Adverse reactionsExact identifier
application number: M012
Oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDEProdose, Inc.3dce34f0-9f6d-8151-e063-6394a90a1d382026-02-11WarningsExact identifier
application number: M012
SIGNATURE CARE Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESAFEWAY831da7b6-25c7-4601-b7f1-1800a238b0162026-02-11WarningsExact identifier
application number: M012
Allergy Plus Congestion ReliefDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0d2cf481-622f-4262-b0bd-c38fe5de67212026-02-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN7eaba464-5cdb-4bd4-b272-38fa108658d52
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD7eaba464-5cdb-4bd4-b272-38fa108658d52
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY7eaba464-5cdb-4bd4-b272-38fa108658d52
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY7eaba464-5cdb-4bd4-b272-38fa108658d52
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY7eaba464-5cdb-4bd4-b272-38fa108658d52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1012-1706771012011 BOTTLE in 1 CARTON (70677-1012-1) / 118 mL in 1 BOTTLE1 bottle2023-04-12NoNoCurrent
70677-1012-2706771012021 BOTTLE in 1 CARTON (70677-1012-2) / 236 mL in 1 BOTTLE1 bottle2023-04-12NoNoCurrent