FDA.reportPublic FDA data

Diphenhydramine hydrochloride

Product NDC
35916-0472
11-digit product format
359160472
Labeler code
35916
Product ID
35916-0472_47db0e8e-5351-a9ae-e063-6394a90aba50
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Softgel Healthcare Pvt Ltd
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-08
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 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
1020477Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
32033991-a4f0-f767-e063-6394a90a0b06Available 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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0472-1Diphenhydramine hydrochloride1000 in 1 BAGCAPSULE, LIQUID FILLED10003
35916-0472-2Diphenhydramine hydrochloride3000 in 1 POUCHCAPSULE, LIQUID FILLED30003
35916-0472-2Diphenhydramine hydrochloride2 in 1 BOXCAPSULE, LIQUID FILLED23
35916-0472-3Diphenhydramine hydrochloride2 in 1 BOXCAPSULE, LIQUID FILLED23
35916-0472-3Diphenhydramine hydrochloride1500 in 1 BAGCAPSULE, LIQUID FILLED15003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35916-0472DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [SOFTGEL HEALTHCARE PVT LTD]1Current NDC, 5 package rows20250410_32033991-a4f0-f767-e063-6394a90a0b06.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 12 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime sleep aid Maximum StrengthDIPHENHYDRAMINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)40e73317-5126-4961-8f28-60899ffbec5a2024-02-20WarningsExact identifier
application number: M010
Nighttime sleep aid Maximum StrengthDIPHENHYDRAMINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)2424fb95-06e2-49e7-aea0-7797a37aef4d2024-02-20WarningsExact identifier
application number: M010
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECVS Pharmacy, Incf5b609e1-e63b-2e3b-e053-2995a90a76b92024-02-12WarningsExact identifier
application number: M010
Kroger Nighttime Sleep Aid CAPLETDIPHENHYDRAMINE HYDROCHLORIDEThe Kroger Co.f0f3f58d-9457-4697-98e6-ef52d350cf672024-01-29WarningsExact identifier
application number: M010
Nighttime Sleep AidNIGHTTIME SLEEP AIDAllegiant Health88feea1d-c961-45e9-b9a6-1418b970aaba2024-01-16WarningsExact identifier
application number: M010
Sleep-Aid Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 110, LLC. DBA Leader4283558d-62df-4297-bc85-a4e06681a9202024-01-11WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEDeMoulas Market Basketd3f35102-94ed-4da0-9c29-312e5468fa052023-12-29WarningsExact identifier
application number: M010
nighttime sleep-aidDIPHENHYDRAMINE HCLBionpharma Inc.c0074c77-287e-6c26-e053-2995a90a4d312023-12-26WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENHYRAMINE HYDROCHLORIDETARGET CORPORATIONfac83dad-f6fd-3316-e053-6394a90a99aa2023-12-21WarningsExact identifier
application number: M010
Nighttime Sleep AidDIPHENYDRAMINE HYDROCHLORIDETARGET CORPORATIONfc7ed67f-bac9-f9ed-e053-6294a90ad9a12023-12-16WarningsExact identifier
application number: M010
Sleep-Aid, Circle KDIPHENHYDRAMINE HCL CAPLET, 25MGLil' Drug Store Products, Inc.d3ad24c4-44ba-6451-e053-2a95a90a13392023-12-14WarningsExact identifier
application number: M010
Nighttime Sleep-AidDIPHENHYDRAMINE HCLVALU MERCHANDISERS COMPANYfed2f7ae-2829-f967-e053-6294a90adc0a2023-10-12WarningsExact identifier
application number: M010
Sleep AidSLEEP AIDBetter Living Brands LLC2b730fa5-47f9-468d-86ed-0d49d9cd8dc42023-07-06WarningsExact identifier
application number: M010
Diphenhydramine HCl 25mgSLEEP AIDAllegiant Health2890e4ba-d642-437d-8a86-24996a74e0272021-11-23WarningsExact identifier
application number: M010
Sleep AidSLEEP AIDAllegiant Health9a0b347e-5719-42f3-9050-df5165495e882021-10-14WarningsExact identifier
application number: M010
Sleep AidDIPHENHYDRAMINE HCLAllegiant Healthec57db48-0f3a-4b12-8633-b45a4366c2692020-11-06WarningsExact identifier
application number: M010

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN32033991-a4f0-f767-e063-6394a90a0b063
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD32033991-a4f0-f767-e063-6394a90a0b063
1020477diphenhydramine HCl 50 MG Oral CapsuleSY32033991-a4f0-f767-e063-6394a90a0b063

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35916-0472-1359160472011000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0472-1) 2025-04-08NoNoCurrent
35916-0472-2359160472022 POUCH in 1 BOX (35916-0472-2) / 3000 CAPSULE, LIQUID FILLED in 1 POUCH2 pouch2025-07-16NoNoCurrent
35916-0472-3359160472032 BAG in 1 BOX (35916-0472-3) / 1500 CAPSULE, LIQUID FILLED in 1 BAG2 bag2026-01-24NoNoCurrent