FDA.reportPublic FDA data

DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
53345-007
11-digit product format
533450007
Labeler code
53345
Product ID
53345-007_2767a338-d7e3-dc51-e063-6394a90a29b2
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-15
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
DIPHENHYDRAMINE HYDROCHLORIDE
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
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6Available 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
53345-007-01DIPHENHYDRAMINE HYDROCHLORIDE20000 in 1 BAGCAPSULE, LIQUID FILLED200004
53345-007-01DIPHENHYDRAMINE HYDROCHLORIDE1 in 1 BOXCAPSULE, LIQUID FILLED14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
SORBITOLINACTIVE INGREDIENT506T60A25RDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-007DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]4Current NDC, Legacy NDC, 2 package rows20241122_9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c6.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 155 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline nasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI07e0328e-1912-4f25-9e1e-9482d4665be02024-09-07WarningsExact identifier
application number: M012
Benadryl Allergy EXTRA STRENGTHDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCdd0a8069-18d8-5696-e053-2995a90a2f222024-09-06WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEPAI Holdings, LLC88d0994c-4270-4408-8837-bd97510b21182024-09-06WarningsExact identifier
application number: M012
QCH Maximum Strength Mucus Relief 617DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.a1c5c15e-0f3a-47d3-b9ed-1e00184175142024-09-06WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Nighttime Soft ChewsACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC6ba64bbe-7599-406a-9187-737c0f8c1c2a2024-09-05WarningsExact identifier
application number: M012
Cough Relief NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)344282fc-3bd1-4f49-9bd1-08c5a58d1f732024-09-05WarningsExact identifier
application number: M012
Equate NasalPHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc95ef1819-edc3-4dda-8514-85b61538cc722024-09-04WarningsExact identifier
application number: M012
Up and up nasalOXYMETAZOLINE HYDROCHLORIDETarget Corporation0c246c11-eadd-4ac6-bd58-5fdb151e06d62024-09-04WarningsExact identifier
application number: M012
Exchange Select NasalOXYMETAZOLINE HYDROCHLORIDEArmy & Air Force Exchange Serviceaafa9163-f08e-48c9-9ca1-7b72f67d007d2024-08-31WarningsExact identifier
application number: M012
nasal 12 hourOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Ince9ee03db-a070-4c2b-ac61-7fd22bab27952024-08-31WarningsExact identifier
application number: M012
dg health nasalOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC42b58928-e8e5-49e4-b49e-498d77d64fcd2024-08-28WarningsExact identifier
application number: M012
nasal mistOXYMETAZOLINE HCLCVS Pharmacyb71c557a-eb93-40d1-87c4-847f5468fc1e2024-08-28WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HCLKroger Company0a24d98a-5950-49de-8b77-ea880b08d2c52024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLC96e018e2-e0b5-4802-a4a1-73a73d5740822024-08-28WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HCLTopco Associates LLCb5434599-5485-4949-9d76-b1ef3ad17c1a2024-08-28WarningsExact identifier
application number: M012
basic care no drip nasalOXYMETAZOLINE HYDROCHLORIDEAmazon.com Services LLCb15eb271-7842-495b-aa0f-9b20def86dc12024-08-28WarningsExact identifier
application number: M012
Topcare NasalOXYMETAZOLINE HYDROCHLORIDETopco Associates LLCf1dd78e0-f700-4469-85d6-18cc299e87462024-08-28WarningsExact identifier
application number: M012
equaline nasalOXYMETAZOLINE HCLUnited Natural Foods, Inc. dba UNFI69308693-a094-42a9-a041-e73647a25cc12024-08-27WarningsExact identifier
application number: M012
signature care nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf9ac80d1-3753-412b-a407-18a6b50e5d1c2024-08-27WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.20ac6010-84f4-eeff-e063-6294a90a50a72024-08-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c64
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD9fc3fb4b-8906-4f4b-bc5d-9cf1e38fd6c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-007-01533450007011 BAG in 1 BOX (53345-007-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2013-09-150000-00-00NoNoCurrent