FDA.reportPublic FDA data

Allergy Relief

Product NDC
70000-0136
11-digit product format
700000136
Labeler code
70000
Product ID
70000-0136_d05a78c9-1c5a-470c-9dc5-4b4bac80b7a8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. DBA Leader
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-02
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
70000-0136-1Allergy Relief2 in 1 CARTONTABLET, FILM COATED216
70000-0136-1Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1216
70000-0136-2Allergy Relief4 in 1 CARTONTABLET, FILM COATED416
70000-0136-2Allergy Relief12 in 1 BLISTER PACKTABLET, FILM COATED1216
70000-0136-3Allergy Relief100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10016
70000-0136-3Allergy Relief1 in 1 CARTONTABLET, FILM COATED116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0136-1EA - Each70000-013697dc2cce-1b77-4f28-a40b-a256e774f18312018-11-06
70000-0136-2EA - Each70000-01360461a31a-eac9-41cd-87a4-d39ca06e592912018-11-06
70000-0136-3EA - Each70000-0136db3beaaa-4f30-43e4-8cb9-7f8626e7546012018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0136ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]15Current NDC, Legacy NDC, 6 package rows20241103_933a54d3-196d-4c5d-b26f-d18b2d2ba1df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN933a54d3-196d-4c5d-b26f-d18b2d2ba1df16
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD933a54d3-196d-4c5d-b26f-d18b2d2ba1df16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0136-1700000136012 BLISTER PACK in 1 CARTON (70000-0136-1) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1990-03-020000-00-00NoNoCurrent
70000-0136-2700000136024 BLISTER PACK in 1 CARTON (70000-0136-2) / 12 TABLET, FILM COATED in 1 BLISTER PACK4 blister pack1990-03-020000-00-00NoNoCurrent
70000-0136-3700000136031 BOTTLE, PLASTIC in 1 CARTON (70000-0136-3) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1990-03-020000-00-00NoNoCurrent