FDA.reportPublic FDA data

Diphenhydramine HCL

Product NDC
71335-0352
11-digit product format
713350352
Labeler code
71335
Product ID
71335-0352_93d7cd9d-2520-4547-9afb-4cedbf82c4c4
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-27
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
59aeb692-2f79-45aa-8e6a-dab77cd3b2f9Available 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
71335-0352-0Diphenhydramine HCL100 in 1 BOTTLECAPSULE1005
71335-0352-1Diphenhydramine HCL30 in 1 BOTTLECAPSULE305
71335-0352-2Diphenhydramine HCL20 in 1 BOTTLECAPSULE205
71335-0352-3Diphenhydramine HCL42 in 1 BOTTLECAPSULE425
71335-0352-4Diphenhydramine HCL24 in 1 BOTTLECAPSULE245
71335-0352-5Diphenhydramine HCL15 in 1 BOTTLECAPSULE155
71335-0352-6Diphenhydramine HCL60 in 1 BOTTLECAPSULE605
71335-0352-7Diphenhydramine HCL10 in 1 BOTTLECAPSULE105
71335-0352-8Diphenhydramine HCL6 in 1 BOTTLECAPSULE65
71335-0352-9Diphenhydramine HCL90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0352-0EA - Each71335-0352a44be06c-8f8a-4660-99d8-7a7882bf4d0412018-01-12
71335-0352-1EA - Each71335-03525724cdf7-db44-4ecd-838f-17736d66b6df12018-01-12
71335-0352-2EA - Each71335-03526e34361e-928d-4c60-8f2b-bbbda1e134c912018-01-12
71335-0352-3EA - Each71335-03523d192aac-57ae-4bb4-abb3-d56c9c8fa1a812018-01-12
71335-0352-4EA - Each71335-035290694670-a454-450e-a41a-39461efef9ba12018-01-12
71335-0352-5EA - Each71335-0352e0303dd6-fb43-4f37-9e03-3394ce3ce49312018-01-12
71335-0352-6EA - Each71335-0352ab09317f-9139-4f6d-8450-63ef1ae8352a12018-01-12
71335-0352-7EA - Each71335-0352f767561f-c9da-4d0c-ae6d-e9b06262b28012018-01-12
71335-0352-8EA - Each71335-0352ad506d73-6c44-4310-974e-2f668f61deed12018-01-12
71335-0352-9EA - Each71335-035278cb66e9-b34d-4181-9cb8-8ec2c8863fcd12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0352DIPHENHYDRAMINE HCL CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20250331_59aeb692-2f79-45aa-8e6a-dab77cd3b2f9.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 38 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company0b34b5a3-98a2-4096-9d95-071bb5a63c862026-04-17WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINWalgreen Company1cd69ede-29c6-4216-95b7-b58fc96c084b2026-04-16WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companycdcb8e0d-7847-4f28-bb09-7dc7b5d35c132026-04-16WarningsExact identifier
application number: M012
Cold Multi-Symptom SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLValu Merchandisers Companyb0d9d869-9f0d-4834-aa2b-1ee21fd8b67b2026-04-16WarningsExact identifier
application number: M012
Rompe Pecho MaxACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc4f86985c-48f3-2148-e063-6394a90ae2f12026-04-15WarningsExact identifier
application number: M012
Childrens Daytime MucusDEXTROMETHORPHAN HBRWalgreens7a55b7e1-1054-421e-847e-5e4d90d1aebb2026-04-15WarningsExact identifier
application number: M012
Childrens Nighttime MucusDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreensdc69f581-27c7-4030-bb18-39685c7691a12026-04-15WarningsExact identifier
application number: M012
Pseudoephedrine HClPSEUDOEPHEDRINE HCLMajor Pharmaceuticalsda95c643-7122-4025-977f-42205080e56b2026-04-15WarningsExact identifier
application number: M012
Daytime Nighttime ChewableDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEWalgreens9ddc0aa7-e7b8-41c5-a2b4-fece0c2e26c62026-04-15WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4f7090f4-89c9-c3da-e063-6294a90a47162026-04-14WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN, PHENYLEPHRINE HCLWalgreen Company2115f095-2d75-4e02-a6af-22dd693e08402026-04-14WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLLidl US LLC00f89eee-0edc-40dc-9297-8645afb910042026-04-14WarningsExact identifier
application number: M012
Sinus Pressure and Pain Daytime Nighttime Maximum StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8647c136-a323-453a-8f57-e66938bbf6392026-04-14WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5515148f-3e1d-4b03-89fa-40967d5082922026-04-14WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc70e6506-6c5b-4d3f-ab18-a690840caabc2026-04-13WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLWalgreen Company48387b95-8240-4d6e-842b-cc29cc18709c2026-04-13WarningsExact identifier
application number: M012
Sinufrin Plus No Drip DecongestantNASAL CONGESTION RELIEFNeilMed Pharmaceuticals Inc4f06c732-1f9f-bfc6-e063-6394a90a53f52026-04-13WarningsExact identifier
application number: M012
Severe Sinus CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8745d9d8-640d-4e3b-96fe-d25032c1e3ce2026-04-13WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 107, LLC5a5c5f33-5b70-465d-a38b-6f518af097882026-04-13WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLPublix Super Markets Incf2263e38-f686-45ed-bf85-b47f5e1aa9822026-04-13WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN59aeb692-2f79-45aa-8e6a-dab77cd3b2f95
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD59aeb692-2f79-45aa-8e6a-dab77cd3b2f95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0352-071335035200100 CAPSULE in 1 BOTTLE (71335-0352-0) 100 capsule2024-04-050000-00-00NoNoCurrent
71335-0352-17133503520130 CAPSULE in 1 BOTTLE (71335-0352-1) 30 capsule2018-10-190000-00-00NoNoCurrent
71335-0352-27133503520220 CAPSULE in 1 BOTTLE (71335-0352-2) 20 capsule2018-11-210000-00-00NoNoCurrent
71335-0352-37133503520342 CAPSULE in 1 BOTTLE (71335-0352-3) 42 capsule2024-04-050000-00-00NoNoCurrent
71335-0352-47133503520424 CAPSULE in 1 BOTTLE (71335-0352-4) 24 capsule2024-04-050000-00-00NoNoCurrent
71335-0352-57133503520515 CAPSULE in 1 BOTTLE (71335-0352-5) 15 capsule2024-04-050000-00-00NoNoCurrent
71335-0352-67133503520660 CAPSULE in 1 BOTTLE (71335-0352-6) 60 capsule2024-04-050000-00-00NoNoCurrent
71335-0352-77133503520710 CAPSULE in 1 BOTTLE (71335-0352-7) 10 capsule2024-04-050000-00-00NoNoCurrent
71335-0352-8713350352086 CAPSULE in 1 BOTTLE (71335-0352-8) 6 capsule2024-04-050000-00-00NoNoCurrent
71335-0352-97133503520990 CAPSULE in 1 BOTTLE (71335-0352-9) 90 capsule2024-04-050000-00-00NoNoCurrent