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 14 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp85a0dc7f-ffb5-7d52-e053-2991aa0a602a2026-07-23WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8590fcc9-c0dd-f43b-e053-2991aa0a692e2026-07-23WarningsExact identifier
application number: M012
Giltuss Sinus and Chest CongestionGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2f2-df65-e053-2a91aa0a42fb2026-07-23WarningsExact identifier
application number: M012
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
application number: M012
nighttime cough dmDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.5a45b4c2-6a15-40b4-9ac6-d1554244ec422026-07-23WarningsExact identifier
application number: M012
DAY TIME NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.6372cbdd-a3a3-499d-91ce-53bcdb83e7392026-07-23WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacydf6e522c-3e30-4aa0-8ab9-3b579c80bcad2026-07-22WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba2026-07-22WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEKenvue Brands LLC1c5386c1-e45d-9dcb-e063-6294a90aff072026-07-22WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp772d0184-8c41-40f1-bbef-7e68692eec662026-07-22WarningsExact identifier
application number: M012
good sense allergyDIPHENHYDRAMINE HCLL. Perrigo Companybf5039a0-2109-41a2-84a9-b5167d0a93da2026-07-22WarningsExact 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