FDA.reportPublic FDA data

NDC 0904-1228-00 - banophen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0904-1228
Requested NDC
0904-1228-00
Package NDCs from labels
0904-1228-00, 0904-1228-20
Manufacturer
Proficient Rx LP
Effective date
2024-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
banophen - Proficient Rx LPProficient Rx LP2024-01-01HUMAN OTC DRUG LABEL
banophen - Major PharmaceuticalsMajor Pharmaceuticals2019-09-25HUMAN OTC DRUG LABEL
banophen - A-S Medication SolutionsA-S Medication Solutions2019-02-01HUMAN OTC DRUG LABEL
Major Pharmaceuticals Banophen™ Drug FactsNuCare Pharmaceuticals,Inc.2017-07-21HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0904-1228-202024-11-05C16284748780-1d6a99b39-84ef-a426-e053-dadaa90af4c2Banophen™ Allergy
0904-1228-202022-01-28C16284748780-1d6a99b39-84ef-a426-e053-dadaa90af4c2Banophen™ Allergy

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-1228-00ML - Milliliter0904-1228119a2b62-49ae-4889-bdd5-72f6b7253d5a12015-01-05
0904-1228-20ML - Milliliter0904-1228e6ecd9ea-596b-49fb-9372-e4b7a497c9ff12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
SORBITOLINACTIVE INGREDIENT506T60A25RBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [MAJOR PHARMACEUTICALS]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2BANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
SORBITOLINACTIVE INGREDIENT506T60A25RBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RBANOPHEN (DIPHENHYDRAMINE HCL) LIQUID [PROFICIENT RX LP]1

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 125 · 2,485 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
unii: TC2D6JAD40
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
unii: TC2D6JAD40
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: TC2D6JAD40
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
Drx Choice childrens allergy chewsDIPHENHYDRAMINE HCLRARITAN PHARMACEUTICALS INCdd2be906-bd0a-437c-9693-54b9391a5da32026-09-05WarningsExact identifier
unii: TC2D6JAD40
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
unii: TC2D6JAD40
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Sleep AidDIPHENHYDRAMINE HCLTARGET Corporationedfe32b5-9213-4350-9508-2530ee26c5d52026-09-02WarningsExact identifier
unii: TC2D6JAD40
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: TC2D6JAD40
KROGER Nighttime Sleep-AidDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYa26d63db-8841-47a4-ae09-ac736d7ec3572026-09-02WarningsExact identifier
unii: TC2D6JAD40
KROGER Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2bea22e9-34b6-4961-94bb-5600dd90e8912026-09-02WarningsExact identifier
rxcui: 1049906
unii: TC2D6JAD40
MAX ALLERGY KIDSDIPHENHYDRAMINE HCLAkron Pharma Inc.96c4ade8-67b1-41e5-8624-fb49090208af2026-09-01WarningsExact identifier
rxcui: 1049906
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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