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 27 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCfe44d1ee-1e03-b74f-e053-6294a90a8bb42026-05-19WarningsExact identifier
application number: M012
MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC325b41e1-f8d2-02ee-e063-6394a90aafff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC326f1fd3-73ab-e515-e063-6294a90ab2222026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC6c85df30-a601-4de6-9fd6-818265d799ff2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7050b583-c09b-4457-9a9c-70c0923b62c02026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC27312ee4-d1f4-4a95-9c45-91fa5a01f5ba2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Daytime Pain, Headache, and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC37de53a7-5546-3804-e063-6294a90a0fb52026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC36b07e49-c72c-45e5-e063-6394a90a804a2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Clear and Cool Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2ee95e17-bd94-d717-e063-6294a90a21732026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus Max Sinus Pressure Severe CongestionOXYMETAZOLINE HCIReckitt Benckiser LLC2eeafd83-230c-af92-e063-6294a90a984e2026-05-19WarningsExact identifier
application number: M012
Mucinex Fast-Max Congestion and Headache Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd7017328-f8af-4601-9232-dc1104feaa0a2026-05-19WarningsExact identifier
application number: M012
Mucinex Rapid Clear Pain Headache and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC32375b12-75ed-d605-e063-6294a90ad0042026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC07da45b5-d05e-41b1-b233-f7034d556a8d2026-05-19WarningsExact identifier
application number: M012
Mucinex Sinus-Max Severe Congestion and Pain Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCad4e0e4d-cc1f-4176-835f-3ba76564c6342026-05-19WarningsExact identifier
application number: M012
Mucinex Childrens Mini Melts Cold and FluACETAMINOPHEN AND GUAIFENESINReckitt Benckiser LLC401fe0a0-ec97-5248-e063-6394a90af27f2026-05-19WarningsExact identifier
application number: M012
Childrens Cough and Congestion, Childrens Cold and Cough Day, NightDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINWALMART INC.312ae879-1124-40a4-b2ba-3f30708400212026-05-19WarningsExact identifier
application number: M012
GOOD SENSE DAYTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2597e84c-18b4-41a9-8e6a-ff0c4c1f06122026-05-18WarningsExact identifier
application number: M012
Childrens Mucus Cough and Congestion ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8b5d391b-6c23-44c3-81d0-c08822bf6d012026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Night Time Multi-Symptom ColdACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCe048cd53-a3cd-484f-a972-4cb49791dba32026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens CoughDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCb8132c81-5291-431a-ad3a-ec8a3eb21c192026-05-18WarningsExact 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