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 118 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HISTEX-DM New FormulationDEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCIAllegis Pharmaceuticals, LLC30010401-e5b4-2bd9-e063-6394a90a0b0b2025-03-10WarningsExact identifier
application number: M012
daytime severe cold multi-symptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcc7c5f1c-76b7-4278-8e2a-5fbc85e022dd2025-03-08WarningsExact identifier
application number: M012
Cold and Head Congestion Relief SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLCa39778ba-1f63-4495-8e9b-44b0bdd7f71a2025-03-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Severe Cough Plus Sore Throat DayACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC2e9540e4-bd1d-9370-e063-6294a90affcb2025-03-07WarningsExact identifier
application number: M012
Herbal Cough Drops Original HerbCOUGH DROPSTopco Associates LLC2fb22181-aee3-d0bf-e063-6294a90a78652025-03-06WarningsExact identifier
application number: M012
REVASOL DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERnv LLC2f9ddcc3-b913-f8b0-e063-6294a90a93ab2025-03-05WarningsExact identifier
application number: M012
Herbal Throat Drops Lemon Mint HerbTHROAT DROPSTopco Associates LLC2fa086b4-3b0e-0df8-e063-6294a90a67692025-03-05WarningsExact identifier
application number: M012
Redicare Nasal and Sinus DecongestantREDICARE NASAL AND SINUS DECONGESTANTRedicare LLC2f24be68-f30e-d916-e063-6294a90a7e312025-03-04WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORAL SOLUTIONKesin Pharma Corporation2f871005-de4d-8b2a-e063-6394a90aa43a2025-03-04WarningsExact identifier
application number: M012
CVS Daytime Cough Relief Chews - Citrus PunchDEXTROMETHORPHAN HBRCVS2f885f1b-7ff5-251b-e063-6394a90a656f2025-03-04WarningsExact identifier
application number: M012
CVS Dex-Dox Kids Nighttime Cough SuppressantDEXTROMETHORPHAN HBRCVS2f8b6f5e-399c-b033-e063-6294a90ac3d12025-03-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCL 25 MGPioneer Life Sciences, LLCff8b096c-8f01-4a8c-a98f-e4aa4d688e952025-03-04WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOL7-ELEVEN2f3c43dd-175f-722e-e063-6294a90acff92025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTIN7-ELEVEN2f3c3c65-4178-6304-e063-6294a90a51fa2025-02-28WarningsExact identifier
application number: M012
Menthol Cough Drops Creamy Strawberry FlavorMENTHOL AND PECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efbffd7-bbdd-c5f5-e063-6294a90a15f02025-02-25WarningsExact identifier
application number: M012
Menthol Cough Drops Honey Vanilla FlavorMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2efc46c9-a421-1998-e063-6394a90aeb642025-02-25WarningsExact identifier
application number: M012
Redicare Cough Drops Cherry FlavoredCHERRY FLAVORED MENTHOL COUGH DROPSRedicare LLC2efeaafa-ee96-37ee-e063-6394a90a9a4b2025-02-25WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLGenexa Inc.e880b8d7-61c3-41cc-e053-2995a90aaaeb2025-02-20WarningsExact identifier
application number: M012
Gencare-Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEPioneer Life Sciences, LLC596ec923-56a0-4b6e-a69c-8d740feb75a22025-02-20WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 2-packACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC77a2dc96-73ee-4ca2-b1fe-4069958026062025-02-19WarningsExact 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