FDA.reportPublic FDA data

Allergy Relief

Product NDC
61504-090
11-digit product format
615040090
Labeler code
61504
Product ID
61504-090_092d4666-dc81-1c0f-e063-6294a90a7aaf
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
AMERIFOODS TRADING COMPANY
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-30
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

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
61504-090-03Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, COATED1002
61504-090-03Allergy Relief1 in 1 CARTONTABLET, COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61504-090ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AMERIFOODS TRADING COMPANY]2Current NDC, 2 package rows20231103_f6cece6c-23e4-7811-e053-6394a90a106a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNf6cece6c-23e4-7811-e053-6394a90a106a2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDf6cece6c-23e4-7811-e053-6394a90a106a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61504-090-03615040090031 BOTTLE, PLASTIC in 1 CARTON (61504-090-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2023-10-30NoNoCurrent