FDA.reportPublic FDA data

Geri-Dryl allergy relief

Product NDC
68788-8104
11-digit product format
687888104
Labeler code
68788
Product ID
68788-8104_6d48cc46-8473-41d1-98e3-fb759a10227d
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
MO12
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-21
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Geri-Dryl allergy relief
Listing expiration
2027-12-31

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
68788-8104-0Geri-Dryl allergy relief10 in 1 BOTTLETABLET, COATED105
68788-8104-1Geri-Dryl allergy relief15 in 1 BOTTLETABLET, COATED155
68788-8104-3Geri-Dryl allergy relief304 in 1 BOTTLETABLET, COATED3045

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8104GERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 3 package rows20250115_7fc05877-6ce8-4b2e-afba-9e043150e1c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN7fc05877-6ce8-4b2e-afba-9e043150e1c55
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD7fc05877-6ce8-4b2e-afba-9e043150e1c55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8104-06878881040010 TABLET, COATED in 1 BOTTLE (68788-8104-0) 2021-10-210000-00-00NoNoCurrent
68788-8104-16878881040115 TABLET, COATED in 1 BOTTLE (68788-8104-1) 2021-10-210000-00-00NoNoCurrent
68788-8104-368788810403304 TABLET, COATED in 1 BOTTLE (68788-8104-3) 2021-10-210000-00-00NoNoCurrent