FDA.reportPublic FDA data

Geri-Dryl allergy relief

Product NDC
57896-683
11-digit product format
578960683
Labeler code
57896
Product ID
57896-683_27ff73c6-59ad-e7b8-e063-6394a90a0133
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-01
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

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
2026-12-31

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
ac8a14ac-7023-1e23-e053-2995a90aea3aAvailable 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
57896-683-01Geri-Dryl allergy relief100 in 1 BOTTLETABLET, COATED1005
57896-683-10Geri-Dryl allergy relief1000 in 1 BOTTLETABLET, COATED10005
57896-683-24Geri-Dryl allergy relief24 in 1 BLISTER PACKTABLET, COATED245
57896-683-24Geri-Dryl allergy relief1 in 1 CARTONTABLET, COATED15
57896-683-40Geri-Dryl allergy relief400 in 1 BOTTLETABLET, COATED4005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-683-01EA - Each57896-6836d8c5acd-83f9-497b-b9e5-3310c9278b4712021-04-08
57896-683-10EA - Each57896-683a8540958-2122-401d-83c6-3fcbedd2c6d412022-01-06
57896-683-40EA - Each57896-683f84d1d0d-f2b3-4a5d-a03c-6d993c0b615e12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-683GERI-DRYL ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 5 package rows20241130_ac8a14ac-7023-1e23-e053-2995a90aea3a.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 123 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEMeijer, Inc.df31056b-d0eb-4094-98d9-3d444210d50d2025-01-16WarningsExact identifier
application number: M012
Childrens Ibuprofen Oral SuspensionIBUPROFENReliable 1 Laboratories LLC28dd9baa-43bd-b60a-e063-6394a90a8cf72025-01-15WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINReliable 1 Laboratories LLCae469d4f-91c4-cff0-e053-2995a90a04972025-01-15WarningsExact identifier
application number: M012
Diphenhydramine HCL 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32f58cb3-941f-263b-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M012
Diphenhydramine HCl 25 mgDIPHENHYDRAMINE HCLReliable 1 Laboratories LLC32fa40ad-fed5-586f-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M012
CVS Health Chest Congestion and Cough HBP SOFTGELDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy, Inc2741ba44-1cc7-1812-e063-6394a90a8faa2025-01-14WarningsExact identifier
application number: M012
DAY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORPORATION2b941963-8a8c-4148-e063-6294a90a1dfb2025-01-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.437e6a13-a4ff-4f98-8973-042f224ee85e2025-01-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.6a520986-1004-4ee6-9a47-1dfd90bb1b2c2025-01-13WarningsExact identifier
application number: M012
good sense daytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company5ddf3283-94e4-465d-842a-471ee946c3302025-01-10WarningsExact identifier
application number: M012
Vicks VapoSteamCAMPHOR (SYNTHETIC)Kaz USA, Incc28da455-07ad-4053-8b9e-fc559f9a3f722025-01-10WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINAphena Pharma Solutions - Tennessee, LLC45ac210a-8c54-4469-8e10-e6fe52b89cb52025-01-09WarningsExact identifier
application number: M012
Meclizine HCLMECLIZINE HCL 25MG CHEWABLE TABLETSAphena Pharma Solutions - Tennessee, LLC02d1af4d-d97d-4019-a5bf-3ec3912386762025-01-09WarningsExact identifier
application number: M012
HISTEX PD Drops New FormulationTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC0c693f15-5d76-3dbf-e063-6294a90af9ac2025-01-08WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HBR 15 MGDEXTROMETHORPHAN HBR 15 MGAMZ789 LLCe2175017-6a0d-0155-e053-2995a90a65d62025-01-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBRHealth Pharma USA LLC29bb7822-76c6-e39d-e063-6294a90a64fb2025-01-07WarningsExact identifier
application number: M012
Childrens Allergy ReliefCHILDRENS ALLERGY RELIEFAllegiant Healthcb6df361-b8e5-4e2f-945f-c20159d76c4f2025-01-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLWinCo Foods, LLCbb7a9fed-dc04-4c31-aa7f-4185d955242c2025-01-06WarningsExact identifier
application number: M012
Leader Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDECardinal Health 110, LLC. dba Leader207b2677-aaad-4fe4-a96d-963b7dcfba702025-01-06WarningsExact identifier
application number: M012
Allergy Relief CapletDIPHENHYDRAMINE HYDROCHLORIDETOPCO ASSOCIATES LLC126c05e7-2cd9-47d3-96c3-82305714e1db2025-01-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN7fc05877-6ce8-4b2e-afba-9e043150e1c55
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNac8a14ac-7023-1e23-e053-2995a90aea3a5
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD7fc05877-6ce8-4b2e-afba-9e043150e1c55
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDac8a14ac-7023-1e23-e053-2995a90aea3a5
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN9ca6c0f8-71d1-4953-8e98-3311c46640113
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD9ca6c0f8-71d1-4953-8e98-3311c46640113
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN2c4e0d5e-958d-4274-876a-52126c795c0f2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD2c4e0d5e-958d-4274-876a-52126c795c0f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-683-0157896068301100 TABLET, COATED in 1 BOTTLE (57896-683-01) 2020-05-010000-00-00NoNoCurrent
57896-683-10578960683101000 TABLET, COATED in 1 BOTTLE (57896-683-10) 2020-04-010000-00-00NoNoCurrent
57896-683-24578960683241 BLISTER PACK in 1 CARTON (57896-683-24) / 24 TABLET, COATED in 1 BLISTER PACK1 blister pack2020-04-010000-00-00NoNoCurrent
57896-683-4057896068340400 TABLET, COATED in 1 BOTTLE (57896-683-40) 2022-04-010000-00-00NoNoCurrent