Geri-Dryl allergy relief

Product NDC
68788-8104
Requested package NDC
68788-8104-3
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68788-810468788-8104-3UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
Geri-Dryl allergy relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7fc05877-6ce8-4b2e-afba-9e043150e1c5Available on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.7fc05877-6ce8-4b2e-afba-9e043150e1c52026-04-06WarningsExact identifier
application number: MO12
ndc (package): 68788-8104-3
ndc (product): 68788-8104
ndc11 (package): 68788810403

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
68788-8104-368788810403304 TABLET, COATED in 1 BOTTLE (68788-8104-3) 2021-10-210000-00-00NoNoCurrent