FDA.reportPublic FDA data

Diphenhydramine HCl

Product NDC
55289-479
11-digit product format
552890479
Labeler code
55289
Product ID
55289-479_30c8d0aa-5859-b584-e063-6394a90ac88e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-01
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
Diphenhydramine HCl
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
1ee41c86-6767-43ca-a5bb-fc685fa662cdAvailable 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
55289-479-10Diphenhydramine HCl10 in 1 BOTTLE, PLASTICCAPSULE1013
55289-479-12Diphenhydramine HCl12 in 1 BOTTLE, PLASTICCAPSULE1213
55289-479-15Diphenhydramine HCl15 in 1 BOTTLE, PLASTICCAPSULE1513
55289-479-20Diphenhydramine HCl20 in 1 BOTTLE, PLASTICCAPSULE2013
55289-479-24Diphenhydramine HCl24 in 1 BOTTLE, PLASTICCAPSULE2413
55289-479-30Diphenhydramine HCl30 in 1 BOTTLE, PLASTICCAPSULE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-479-10EA - Each55289-47984337d3c-4e51-4f04-ba31-36319e491ca112021-04-08
55289-479-12EA - Each55289-479f7991a85-0178-4da1-9abf-07ded7f5b8a612021-04-08
55289-479-15EA - Each55289-4793905f5b0-bc5b-4e4c-89b1-d574ae5f918612021-04-08
55289-479-20EA - Each55289-4791005b8a3-28e3-4239-9025-3da6e8b04db212021-04-08
55289-479-24EA - Each55289-4799e0d001d-f263-4ead-96fd-505af9961adb12021-04-08
55289-479-30EA - Each55289-479f815e227-05c8-42d3-a135-1325e7c40f6612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-479DIPHENHYDRAMINE HCL CAPSULE [PD-RX PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 6 package rows20250322_1ee41c86-6767-43ca-a5bb-fc685fa662cd.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 10 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Inc.6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f2024-12-02WarningsExact identifier
application number: M010
Diphenhydramine HClDIPHENHYDRAMINE HCLCVS Pharmacy, Inc.6dd802ec-fc26-3913-e053-2a91aa0ad05d2024-12-02WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDEPUBLIX SUPER MARKETS INC236ff457-0ec1-9c49-e063-6394a90a707a2024-11-26WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.50d74111-6d1b-4681-a264-f7e5503202592024-11-25WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.efb05387-72c0-4643-8541-b7990c202ce62024-11-25WarningsExact identifier
application number: M010
Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6ozDIPHENHYDRAMINE HCL SOLUTIONLil' Drug Store Products, Inc.2781fc28-8a7d-d0fa-e063-6394a90ac7932024-11-22WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.7830ce18-908a-4f86-a238-8c31cfe47ce62024-11-21WarningsExact identifier
application number: M010
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.f8de6605-4a0a-492d-beb5-f414ce8bfb0e2024-11-20WarningsExact identifier
application number: M010
Nighttime SLEEP AIDDIPHENHYDRAMINE HCL 50MGPuraCap Pharmaceutical LLC272a7138-2a97-8e62-e063-6394a90a1af12024-11-18WarningsExact identifier
application number: M010
ZzzQuilDIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.0b2777be-85d4-443d-b65f-6750e0ba97ba2024-11-18WarningsExact identifier
application number: M010
RiteAid Nighttime Sleep AidDIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHENRITE AID CORPORATION54fc0893-9702-4849-a702-3e84dc9ead032024-10-30WarningsExact identifier
application number: M010
Rite Aid Nighttime Sleep Aid Non Habit FormingDIPHENHYDRAMINE HYDROCHLORIDERITE AID CORPORATION59ba6824-fa6c-4b3f-9f1f-ea194766c8a12024-10-30WarningsExact identifier
application number: M010
GOOD REMEDIES Nighttime Sleep Aid CapletsDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.24fba735-cedf-9d15-e063-6394a90af8732024-10-29WarningsExact identifier
application number: M010
Premier Value Nighttime Sleep-Aid Liquid Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Consortium6d24b6e1-7959-47c6-a09b-c7e00a4374952024-10-28WarningsExact identifier
application number: M010
NytolDIPHENHYDRAMINE HCLMedtech Products Inc.c81d018a-0170-4396-81e9-2e13a53f868a2024-10-25WarningsExact identifier
application number: M010
Rest SimplyDIPHENHYDRAMINE HYDROCHLORIDEMarc Glassman, Inc.2ab3852d-53a4-411b-a9ad-3ef88ab3ee872024-10-23WarningsExact identifier
application number: M010
nitetime sleep aidDIPHENHYDRAMINE HCLMeijer Distribution Inc43184abd-2525-402a-a388-85af2e5c13ad2024-10-17WarningsExact identifier
application number: M010
Good Sense Sleep TimeDIPHENHYDRAMINE HCLL. Perrigo Company164200a9-b1f8-44c9-8598-a7dff5020e9d2024-10-16WarningsExact identifier
application number: M010
Equaline Night Time Sleep AidDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI6d34ee3e-3d61-481e-98d6-acfa066e42472024-10-16WarningsExact identifier
application number: M010
basic care nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLC027de5ea-5c07-4960-8a98-8cf2c0e54a922024-10-16WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1ee41c86-6767-43ca-a5bb-fc685fa662cd13
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1ee41c86-6767-43ca-a5bb-fc685fa662cd13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-479-105528904791010 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-10) 10 capsule2021-03-270000-00-00NoNoCurrent
55289-479-125528904791212 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-12) 12 capsule2021-03-270000-00-00NoNoCurrent
55289-479-155528904791515 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-15) 15 capsule2021-03-270000-00-00NoNoCurrent
55289-479-205528904792020 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-20) 20 capsule2021-03-270000-00-00NoNoCurrent
55289-479-245528904792424 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-24) 24 capsule2021-03-270000-00-00NoNoCurrent
55289-479-305528904793030 CAPSULE in 1 BOTTLE, PLASTIC (55289-479-30) 30 capsule2018-07-110000-00-00NoNoCurrent