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 111 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC8188b66a-5405-4e62-bde6-63ebc1f22b162025-07-04WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEMeijer, Inc.fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a2025-07-03WarningsExact identifier
application number: M012
Cabinet Allergy Relief Refill Diphenhydramine HCIDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.d47553a4-ca15-4f0a-8177-d743a5c39cc52025-07-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAdvanced Rx LLC20e164b8-4cbc-cf3f-e063-6394a90a9d0c2025-07-02WarningsExact identifier
application number: M012
24/7 Life Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENTLil' Drug Store Products, Inc.f03430d4-8dbb-4fc0-e053-2a95a90a119d2025-07-02WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limitedb109249a-a0be-41bd-b6ce-ef621b588ddc2025-07-02WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLCVS Pharmacy91c803c8-6cf8-4ff6-b376-ea6d65f9f2272025-07-01WarningsExact identifier
application number: M012
WALGREENS Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALGREENS CO.cc2fdc6b-8319-47c8-b036-37dbd65d58332025-06-30WarningsExact identifier
application number: M012
WALGREENS Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALGREENS CO.91c369b0-8620-4764-a85d-a86402d9489c2025-06-30WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDEPioneer Life Sciences, LLCbb9a82b1-ea7a-4d10-bc00-05013e83c4d32025-06-30WarningsExact identifier
application number: M012
Daytime and Nighttime Cherry Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS, LLC202f0661-461c-0333-e063-6294a90a96b52025-06-28WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCVS Pharmacyf038b713-0721-2bb5-e053-2a95a90a78422025-06-26WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLCbb728ceb-8eb0-4192-a8b0-742756819a052025-06-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDETIME CAP LABORATORIES, INC7aee34b5-1583-4a8a-8ffb-b17ef2722ac12025-06-25WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWALGREENSc0270298-e7c5-e500-e053-2995a90aed232025-06-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.24ff91f2-02db-56a2-e063-6394a90a31c92025-06-25WarningsExact identifier
application number: M012
Cough and Chest Congestion Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.e920b700-30d3-3266-e053-2a95a90a06392025-06-24WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2ffe0fbc-236d-417b-bbfd-5b9294f3c90a2025-06-23WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38034ad2-5eab-9caf-e063-6294a90abb8f2025-06-20WarningsExact identifier
application number: M012
Herbal Cough DropsHERBAL MENTHOLMeijer, Inc.380364be-4e52-fa52-e063-6394a90a713c2025-06-20WarningsExact 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