FDA.reportPublic FDA data

Good NeighborChildrens Allergy Relief

Product NDC
46122-793
11-digit product format
461220793
Labeler code
46122
Product ID
46122-793_483c28ee-77a8-4854-b53e-2a18bb925ae1
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
AMERISOURCE BERGEN
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-24
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
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
Good NeighborChildrens Allergy Relief
Brand name suffix
Bubblegum flavor
Listing expiration
2027-12-31

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
f442c61b-7d2c-401c-b862-acbe2282927bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-793-29Good NeighborChildrens Allergy ReliefBubblegum flavor118 mL in 1 BOTTLE, PLASTICLIQUID1183
46122-793-29Good NeighborChildrens Allergy ReliefBubblegum flavor1 in 1 CARTONLIQUID13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-793-29ML - Milliliter46122-7930eef124f-debc-4929-9f28-223df42eb59e12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-793GOOD NEIGHBORCHILDRENS ALLERGY RELIEF BUBBLEGUM FLAVOR (DIPHENHYDRAMINE HCL) LIQUID [AMERISOURCE BERGEN]2Current NDC, 2 package rows20241017_f442c61b-7d2c-401c-b862-acbe2282927b.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 49 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals04e70311-6412-4a20-84e3-f6e26d5f19ab2026-02-20WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals7f2b72cc-d4f7-431f-be61-c103cf8c489e2026-02-20WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticalsdca04d80-e781-40b1-e053-2995a90a70102026-02-20WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.e33cbd1d-1848-145a-e053-2995a90aeb502026-02-20WarningsExact identifier
application number: M012
Head Congestion and Flu Severe ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation416080a9-e817-485b-a4ae-6c9d0152c1652026-02-20WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALMART STORES INC18436026-b0e4-4481-a647-d735a27d0b002026-02-19WarningsExact identifier
application number: M012
VaporizingCAMPHORMeijer, Inc.7afc98d7-f64f-42d5-9022-28ad6b01db8a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M012
CHILDRENS COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEKroger Company8196b482-070e-4d7d-8943-129141f926ee2026-02-19WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy Chews BubblegumDIPHENHYDRAMINE HCLWALMART STORES INC9f83d2f0-9718-4f2b-bc7f-e29ba29174122026-02-19WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINKroger Companybe9aaf66-6c59-4042-88e2-acd920dcf9922026-02-19WarningsExact identifier
application number: M012
Allergy Relief Dye-FreeDIPHENHYDRAMINE HCLCVS Pharmacy08459cf4-feb3-4283-88e1-d61e030c57f92026-02-19WarningsExact identifier
application number: M012
allergy reliefCHLORPHENIRAMINE MALEATERite Aid Corporationb0d70488-ea1d-4c1d-bd07-53dfb0e4d03c2026-02-18WarningsExact identifier
application number: M012
Walgreens Wild Cherry Pectin Throat DropsPECTINWalgreens424fda2d-c1e5-0ed9-e063-6394a90a06ea2026-02-18WarningsExact identifier
application number: M012
cough suppressant and topical analgesicCAMPHOR, EUCALYPTUS OIL, MENTHOLTarget Corporationdf21d9d6-36a9-49cf-a29c-c4a573899bd52026-02-18Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEAmerisource Bergeneeda80ff-212d-428e-a0c6-782f271357b42026-02-18WarningsExact identifier
application number: M012
good sense night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companye47dffdf-5778-4804-8ce2-54c5a72bba3a2026-02-18WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLUnited Natural Foods, Inc. dba UNFIb139e7d6-bf4d-45b9-b7cf-d34e5352095c2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLStrategic Sourcing Services LLCbd54bf7a-2304-4c3f-9cd2-bafea217466e2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Creomulsion For ChildrenDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d0e96c-1cc3-4961-e054-00144ff88e882026-02-17WarningsExact identifier
application number: M012
Creomulsion Cough Medicine Adult FormulaDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d07486-99b7-5c06-e054-00144ff8d46c2026-02-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNf442c61b-7d2c-401c-b862-acbe2282927b3
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDf442c61b-7d2c-401c-b862-acbe2282927b3
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYf442c61b-7d2c-401c-b862-acbe2282927b3
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYf442c61b-7d2c-401c-b862-acbe2282927b3
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYf442c61b-7d2c-401c-b862-acbe2282927b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
46122-793-29461220793291 BOTTLE, PLASTIC in 1 CARTON (46122-793-29) / 118 mL in 1 BOTTLE, PLASTIC2024-06-24NoNoCurrent