FDA.reportPublic FDA data

Allergy

Product NDC
69168-048
11-digit product format
691680048
Labeler code
69168
Product ID
69168-048_b53853c5-5f00-41ab-8d0d-eb40aba6e67b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-15
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
Allergy
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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c2823bad-540f-4662-8dcc-58e9f0d94efbAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69168-048-012020-03-13Drug Facts
69168-048-932020-03-13Drug Facts
69168-048-012020-01-31Drug Facts
69168-048-932020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-048-01Allergy100 in 1 BOTTLETABLET1006
69168-048-20Allergy600 in 1 BOTTLETABLET6006
69168-048-93Allergy2 in 1 BOXTABLET26
69168-048-93Allergy12 in 1 BLISTER PACKTABLET126
69168-048-98Allergy200 in 1 BOTTLETABLET2006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-048ALLERGY (DIPHENHYDRAMINE HCL) TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 5 package rows20231109_c2823bad-540f-4662-8dcc-58e9f0d94efb.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 117 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.87ebb4d9-78d7-1c87-e053-2a95a90adb7d2025-03-27WarningsExact identifier
application number: M012
REVASOL CHILDRENS ALLERGYDIPHENHYDRAMINE HCLRnv LLC3143137f-ef42-5358-e063-6394a90a8ed12025-03-26WarningsExact identifier
application number: M012
Rompe Pecho SF FLUDEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEEfficient Laboratories Incbc10695a-9664-4ce3-82bb-820da06129fa2025-03-26WarningsExact identifier
application number: M012
SUPRESS-PE PediatricGUIAFENESIN, PHENYLEPHRINE HCLKramer Novisa474171d-5c29-4a80-9d37-00613796211a2025-03-26WarningsExact identifier
application number: M012
Guaifenesin DMDEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESINInnovida Pharmaeutique Corporationdd3f806b-2470-4055-94e1-18adac8110252025-03-25WarningsExact identifier
application number: M012
Foster and Thrive childrens cold cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC38b710e3-1d01-4ff4-a6b6-44936f277f492025-03-25WarningsExact identifier
application number: M012
Revasol Tussin DM Max with HoneyDEXTROMETHORPHAN HBR AND GUAIFENESINRnv LLC30da9255-c93a-84d6-e063-6394a90a7c2a2025-03-21WarningsExact identifier
application number: M012
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINMeijer, Inc.261a79b3-5704-76f2-e063-6394a90a5ac62025-03-20WarningsExact identifier
application number: M012
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
application number: M012
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
application number: M012
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
application number: M012
Halls Sugar Free Black CherryMENTHOLMondelez Global LLCbd2a311a-bf0c-4365-af9b-76675c243b222025-03-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTARGET CORPORATIONfbca9627-5e12-048a-e053-6294a90a6e0f2025-03-15WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLDOLGENCORP, INC.0655688e-7c42-507f-e063-6294a90ae4982025-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY, INC1b8d5494-1fcf-4cd0-acc0-34f17d577bd72025-03-14WarningsExact identifier
application number: M012
Ultra Concentrated Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300b2357-933b-fe9a-e063-6294a90aa4b92025-03-11WarningsExact identifier
application number: M012
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
application number: M012
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
application number: M012
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNc2823bad-540f-4662-8dcc-58e9f0d94efb6
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDc2823bad-540f-4662-8dcc-58e9f0d94efb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-048-0169168004801100 TABLET in 1 BOTTLE (69168-048-01) 100 tablet2014-12-150000-00-00NoNoCurrent
69168-048-2069168004820600 TABLET in 1 BOTTLE (69168-048-20) 600 tablet2020-03-220000-00-00NoNoCurrent
69168-048-93691680048932 BLISTER PACK in 1 BOX (69168-048-93) / 12 TABLET in 1 BLISTER PACK2 blister pack2014-12-150000-00-00NoNoCurrent
69168-048-9869168004898200 TABLET in 1 BOTTLE (69168-048-98) 200 tablet2022-05-180000-00-00NoNoCurrent