FDA.reportPublic FDA data

Allergy Relief

Product NDC
46122-685
11-digit product format
461220685
Labeler code
46122
Product ID
46122-685_05a91e96-7540-4529-bd47-4d6cebe51d91
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Amerisource Bergen
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-26
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/20mL
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

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

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
46122-685-26Allergy Relief118 mL in 1 BOTTLE, PLASTICSOLUTION11810
46122-685-26Allergy Relief1 in 1 CARTONSOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-685-26ML - Milliliter46122-685ae73f68e-d9ce-43d6-91ab-d8be89e47d2b12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-685ALLERGY RELIEF (DIPHENHYDRAMINE HCL) SOLUTION [AMERISOURCE BERGEN]8Current NDC, Legacy NDC, 2 package rows20250130_8e0c6f8d-559c-45de-9362-1b713fd78a7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN8e0c6f8d-559c-45de-9362-1b713fd78a7a10
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD8e0c6f8d-559c-45de-9362-1b713fd78a7a10
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY8e0c6f8d-559c-45de-9362-1b713fd78a7a10
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY8e0c6f8d-559c-45de-9362-1b713fd78a7a10
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY8e0c6f8d-559c-45de-9362-1b713fd78a7a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-685-26461220685261 BOTTLE, PLASTIC in 1 CARTON (46122-685-26) / 118 mL in 1 BOTTLE, PLASTIC2021-01-260000-00-00NoNoCurrent