FDA.reportPublic FDA data

Benadryl

Manufacturer
Kenvue Brands LLC
Effective date
2026-07-28
Label type
HUMAN OTC DRUG LABEL
Version
32
Source
daily-update
Hydrated at
2026-08-01 05:10:14

Label at a glance#

ProductBenadryl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 tablets children 6 to under 12 years 1 tablet children under 6 years do not use

Storage and handling

each tablet contains: calcium 15 mg store between 20-25°C (68-77°F). Protect from light. do not use if blister unit is torn or broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold:
    • runny nose
    • sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over1 to 2 tablets
children 6 to under 12 years1 tablet
children under 6 yearsdo not use

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 15 mg
  • store between 20-25°C (68-77°F). Protect from light.
  • do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, D&C red no. 27 aluminum lake, dibasic calcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-717-2824 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

See Opening Directions

NDC 50580-226-12

Benadryl ®

ALLERGY

Diphenhydramine HCl 25mg | Antihistamine

✓ Sneezing

✓ Runny Nose

✓ Itchy, Watery Eyes

✓ Itchy Throat

ULTRATABS ®*

*small tablet size

actual size

12 TABLETS

Benadryl-1Benadryl-1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300450171122GTIN-13: 0300450171122
EAN-13: 0300450171122
GTIN-12: 300450171122
UPC-A: 300450171122
GTIN storage (14 digits): 00300450171122		Benadryl-1.jpg
QR code linkQR Code2d.kenvue.com/01/00300450171122Benadryl-1.jpg

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-226-502024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-502024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-502024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-02-06C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-502024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-502024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-502024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-512024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-522024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-532024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-542024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-562024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®
50580-226-622024-01-30C16284748780-11030e365-46c8-111a-e063-dadaa90a10e2Benadryl ®

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-226-10EA - Each50580-2260e538188-3b26-4cf7-a5d2-7653a4c5807f12012-07-24
50580-226-48EA - Each50580-22630dcc89c-a992-45e8-84cd-964543091fb312012-07-24
50580-226-50EA - Each50580-2260c74e638-fdc6-4e03-aa02-8f64c6b47a2c12017-12-14
50580-226-51EA - Each50580-2264b1c6774-52e1-41f4-bb46-9e341575620012013-04-01
50580-226-52EA - Each50580-22605a4b0af-3905-4b1c-88a4-3fb4f226675b12015-10-02
50580-226-54EA - Each50580-226e04fc601-d017-4bc6-94ae-ecd6715d9b2f12022-02-07
50580-226-62EA - Each50580-226f56d0e68-9dd8-4cf9-b5cd-ac5e7c49552b12019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD407
DiphenhydramineACTIVE MOIETY8GTS82S83M7
Aluminum OxideINACTIVE INGREDIENTLMI26O69337
Calcium Phosphate, Dibasic, DihydrateINACTIVE INGREDIENTO7TSZ97GEP7
Carnauba WaxINACTIVE INGREDIENTR12CBM0EIZ7
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61U7
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH487
CrospovidoneINACTIVE INGREDIENT68401960MK7
D&C Red no. 27INACTIVE INGREDIENT2LRS185U6K7
HypromellosesINACTIVE INGREDIENT3NXW29V3WO7
Magnesium StearateINACTIVE INGREDIENT70097M6I307
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1A7
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8H7
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP7
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP7

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-22650580-226-50, 50580-226-51, 50580-226-53, 50580-226-54, 50580-226-62, 50580-226-52, 50580-226-56, 50580-226-20, 50580-226-70, 50580-226-12, 50580-226-33

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C RED NO. 27 ALUMINUM LAKEZK64F7XSTXIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYSORBATE 806OZP39ZG8HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
312026-02-06full-release2026-06-01 01:37:45
302026-01-16monthly-update2026-06-03 17:53:14

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 168 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
48 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
48 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Aluminum OxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Calcium Phosphate, Dibasic, DihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
48 equally ranked IID candidates
Magnesium StearateMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
48 equally ranked IID candidates
Aluminum OxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
48 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Calcium Phosphate, Dibasic, DihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
48 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Calcium Phosphate, Dibasic, DihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
48 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
48 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
48 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Aluminum OxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates
Aluminum OxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
Carnauba WaxCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
48 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Aluminum OxideALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
Calcium Phosphate, Dibasic, DihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET / ORAL1 mgExact identifier — unii+route
48 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KTABLET, EXTENDED RELEASE / ORAL1.43 mgExact identifier — unii+route
48 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Croscarmellose SodiumCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
HypromellosesHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Cellulose, MicrocrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Polysorbate 80POLYSORBATE 806OZP39ZG8HTABLET, FILM COATED / ORAL24 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
Calcium Phosphate, Dibasic, DihydrateDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
12 equally ranked IID candidates
D&C Red no. 27D&C RED NO. 272LRS185U6KPOWDER, FOR SUSPENSION / ORAL1.67 mg/5mlExact identifier — unii+route
48 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
ndc (package): 50580-226-50
ndc (package): 50580-226-70
ndc (package): 50580-226-54
ndc (package): 50580-226-33
ndc (package): 50580-226-20
ndc (package): 50580-226-51
ndc (package): 50580-226-53
ndc (package): 50580-226-12
ndc (package): 50580-226-56
ndc (package): 50580-226-62
ndc (package): 50580-226-52
ndc (product): 50580-226
ndc11 (package): 50580022653
ndc11 (package): 50580022656
ndc11 (package): 50580022612
ndc11 (package): 50580022652
ndc11 (package): 50580022620
ndc11 (package): 50580022651
ndc11 (package): 50580022650
ndc11 (package): 50580022654
ndc11 (package): 50580022633
ndc11 (package): 50580022662
ndc11 (package): 50580022670
spl id: 57a6b529-75db-f06e-e063-6294a90a7dd3
spl set id: 702f9786-7ce9-43e4-921d-e1db09612127

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.