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 136 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICE Honey Lemon Cough DropsMENTHOLLeosons Overseas Corp96da2c9d-2d0d-6252-e053-2995a90ac3382024-11-19WarningsExact identifier
application number: M012
SanaTos BoostDEXTROMETHORPHAN HBRPharmadel LLCae6a424f-f3f0-3f6c-e053-2995a90a972d2024-11-18WarningsExact identifier
application number: M012
SanaTos Turbo Max StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLCd56a071c-a747-5397-e053-2995a90aad8b2024-11-18WarningsExact identifier
application number: M012
equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa24021a0-ef68-4bce-ba53-d262d1025cc02024-11-17WarningsExact identifier
application number: M012
Cold and Cough DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Inc4d5f93c1-7752-4948-ba58-c4385cfc24c82024-11-17WarningsExact identifier
application number: M012
Good Sense Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company8a87104f-94a4-4585-afd5-d610eea32e392024-11-17WarningsExact identifier
application number: M012
equate childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Incc91e94f4-4c51-4fe7-ad2e-0b9dc58b51e42024-11-17WarningsExact identifier
application number: M012
foster and thrive childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services LLC1eac715b-351c-4b47-8d1d-6e921813c1a42024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC298d2796-5ae5-4346-b6d2-2ced2dd29dc32024-11-15WarningsExact identifier
application number: M012
dg health day time severe cold and flu relief night time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEDolgencorp, LLCf721b393-9ad5-4fc6-a2c5-bd89e58caf162024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC9f4daadb-fdaf-4ea9-bad9-7ed9f8cee7f22024-11-15WarningsExact identifier
application number: M012
Rompe Pecho EXGUAIFENESINEfficient Laboratories Inc89ea23a5-0da7-407e-83d9-77a0b562f3af2024-11-14WarningsExact identifier
application number: M012
basic care daytime cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLCceb342da-ff6d-4c19-9f78-0033d028075e2024-11-14WarningsExact identifier
application number: M012
Topcare Nite Time Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTopco Associates LLCefb8e0e2-0795-4f4a-8ca6-955f33bee1432024-11-14WarningsExact identifier
application number: M012
good neighbor pharmacy nasal fourPHENYLEPHRINE HYDROCHLORIDEAmerisource Bergena3d637dc-d957-458c-8a75-f948601a31aa2024-11-14WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer Distribution Incec8db98f-4fd1-4644-b76f-ff04f72e87f42024-11-13WarningsExact identifier
application number: M012
dg health tussinDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, LLC6f9b8267-1e0b-430b-8e44-06408ae82ea42024-11-13WarningsExact identifier
application number: M012
Walgreens Effervescent Cold Relief PlusASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEWalgreensb60e2cf9-11ec-469e-e053-2a95a90a712a2024-11-13WarningsExact identifier
application number: M012
Kroger Effervescent Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEKroger Company69333774-3cf4-384d-e053-2a91aa0a48b32024-11-13WarningsExact identifier
application number: M012
Effervescent Orange Cold ReliefASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEH. E. Butt Grocery Company6403fe3d-d82b-f4d5-e053-2991aa0ac7d62024-11-13WarningsExact 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