FDA.reportPublic FDA data

NDC 69238-2016-03 - Ipratropium Bromide

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
69238-2016
Requested NDC
69238-2016-03
Package NDCs from labels
69238-2016-3, 69238-2016-03
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC
Effective date
2023-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IPRATROPIUM - Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC2023-12-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2016-3Ipratropium Bromide345 in 1 BOTTLE, SPRAYSPRAY34510
69238-2016-3Ipratropium Bromide1 in 1 CARTONSPRAY110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2016IPRATROPIUM BROMIDE SPRAY [AMNEAL PHARMACEUTICALS NY LLC]10Current NDC, Legacy NDC, 2 package rows20231231_61820346-29d9-4864-b8f4-4a198b8ac594.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2016-3ML - Milliliter69238-2016ef06f780-e7d5-4f2d-9a28-2e5220b26e3512022-12-07

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 40 of 110 · 2,191 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel 4X Medicated For Toothache and Gum, CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999aa7b9-bf9e-9285-e053-2a95a90a345b2025-12-12WarningsExact identifier
unii: F5UM2KM3W7
Orajel 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
unii: F5UM2KM3W7
IPRATROPIUM BROMIDEIPRATROPIUM BROMIDEAdvagen Pharma Ltdbb5f7711-595f-4f7c-9e89-66d029ccbccb2025-12-12Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry BerryBENZALKONIUM CHLORIDEKAS Direct LLC dba BabyGanics75ae3b5e-b583-4b80-b4ab-5cc40978ca302025-12-12WarningsExact identifier
unii: F5UM2KM3W7
HEADACHE HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
unii: 451W47IQ8X
Cell WellCALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAJoyWell Co LLC592c1f48-21c8-4ff5-8818-046662c9effe2025-12-11WarningsExact identifier
unii: 451W47IQ8X
Dial Antibacterial Vitamin BarDIAL ANTIBACTERIAL VITAMIN BAR SOAPHenkel Corporation292bf620-5cde-388d-e063-6394a90a307c2025-12-11WarningsExact identifier
unii: F5UM2KM3W7
Bright Amber AntibacterialBENZALKONIUM CHLORIDEColgate-Palmolive Company44f9cf18-dd2d-4637-a5e1-3db82a1904ff2025-12-11WarningsExact identifier
unii: F5UM2KM3W7
SinuCleanseSODIUM BICARBONATE, SODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.beb842fa-2373-4f21-9631-ef20ee1245842025-12-10WarningsExact identifier
unii: 451W47IQ8X
Ipratropium BromideIPRATROPIUM BROMIDERitedose Pharmaceuticals, LLC22479633-624a-4251-ad3c-1dcba5d503fb2025-12-10Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
IPRATROPIUM BROMIDE AND ALBUTEROL SULFATEIPRATROPIUM BROMIDE AND ALBUTEROL SULFATERitedose Pharmaceuticals, LLCe0dee492-8bf9-4360-be9b-9d6ee1ecb2562025-12-10Warnings, Adverse reactionsExact identifier
unii: J697UZ2A9J
All natural Saline Packets CareOneSODIUM BICARBONATE, SODIUM CHLORIDEFOODHOLD U.S.A.e32f105d-65cd-8095-e053-2995a90a9b6b2025-12-10WarningsExact identifier
unii: 451W47IQ8X
HurriCaine OneTOPICAL ANESTHETIC AND ANTISEPTICBeutlich Pharmaceuticals LLC459cedbd-9b6f-e450-e063-6394a90afb732025-12-10WarningsExact identifier
unii: F5UM2KM3W7
Dial Professional Antibacterial Defense Spring WaterBENZALKONIUM CHLORIDEHenkel Corporation29644a9d-3954-a6e5-e063-6394a90a82c72025-12-09WarningsExact identifier
unii: F5UM2KM3W7
Dial Professional Antibacterial Foaming Hand Wash Spring WaterDIAL PROFESSIONAL ANTIBACTERIAL FOAMING HAND SOAP SPRING WATER SCENTHenkel Corporation28dc867c-ca9b-4631-e063-6394a90a9a352025-12-09WarningsExact identifier
unii: F5UM2KM3W7
Rhinomel ManukaSODIUM CHLORIDEMelcare Biomedical Pty Ltd35a7ce7d-4a26-e3f0-e063-6294a90ad66f2025-12-09WarningsExact identifier
unii: 451W47IQ8X
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
BabyGanics Kids Alcohol Free Foaming Hand Sanitizer Berry BerryBENZALKONIUM CHLORIDEKAS Direct LLC dba BabyGanics56b559c6-db10-47dd-9316-cc2d04cbef982025-12-08WarningsExact identifier
unii: F5UM2KM3W7
Babyganics Alcohol-Free Hand Sanitizer Wipes MandarinBENZALKONIUM CHLORIDEKAS Direct, LLCd93300b3-2c9b-4623-ae4b-907e857ce5ae2025-12-08WarningsExact identifier
unii: F5UM2KM3W7
Betadine Foam CleanserBENZALKONIUM CHLORIDEAtlantis Consumer Healthcare, Inc.3be9fa6e-3ae8-496b-876b-f81f1cd98af42025-12-05WarningsExact identifier
unii: F5UM2KM3W7

Reported adverse events (FAERS/openFDA)#

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