FDA.reportPublic FDA data

NDC 41167-4232-06 - Childrens Allegra Allergy

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
41167-4232
Requested NDC
41167-4232-06
Package NDCs from labels
41167-4232-1, 41167-4232-6, 41167-4232-06
Manufacturer
Chattem, Inc.
Effective date
2025-02-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Childrens Allegra AllergyChattem, Inc.2025-02-18HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-4232-1Childrens Allegra Allergy6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING616
41167-4232-1Childrens Allegra Allergy2 in 1 CARTONTABLET, ORALLY DISINTEGRATING216
41167-4232-6Childrens Allegra Allergy6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING616
41167-4232-6Childrens Allegra Allergy4 in 1 CARTONTABLET, ORALLY DISINTEGRATING416

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-4232CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]16Current NDC, Legacy NDC, 4 package rows20250216_06115cea-5a44-409d-85ed-bb71743491c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-4232-1EA - Each41167-42326d240a7a-34be-4ec9-8d4e-64c16914377c12014-07-02
41167-4232-6EA - Each41167-4232ade41b16-b68e-4f99-accc-afc2032c379812016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
FEXOFENADINEACTIVE MOIETYE6582LOH6VCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94ECHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHILDRENS ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [CHATTEM, INC.]6

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 24 of 44 · 871 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.8afc0167-17bf-4ccd-91c9-8fb9c4e241c12025-03-11WarningsExact identifier
unii: 2S068B75ZU
fexofenadine hclFEXOFENADINE HCLRadha Pharmaceuticals30283df1-6394-3a91-e063-6394a90a67762025-03-10WarningsExact identifier
unii: 2S068B75ZU
Allergy ReliefFEXOFENADINE HYDROCHLORIDEFSA STORE INC.276e9767-93c0-5932-e063-6394a90ab2d92025-03-07WarningsExact identifier
unii: 2S068B75ZU
Bestmade Natural Products BM231ABROTANUM, ANTI IOD, ARSENIC IOD, BARYTA CARB, CALC PHOS, FERR MET, KALI IOD, SILICEABestmade Natural Products2f81507c-b5b0-a976-e063-6394a90a869e2025-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM237BELLADONA, BARYTA CARB, HEPAR SULPH, KALI BICH, MERC IOD FLAV, MERC IOD RUB, SILICEABestmade Natural Products2f82f2c4-a549-9e17-e063-6394a90aea812025-03-04WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM214CARBO VEG, FERRUM PHOS, SILICA, KALI CARB, CALC PHOS, NAT MURBestmade Natural Products2f6e08d8-a6f9-c049-e063-6394a90a6df12025-03-03WarningsExact identifier
unii: ETJ7Z6XBU4
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
SiliceaSILICON DIOXIDEWashington Homeopathic Products2ee71a08-f69b-e2ef-e063-6394a90ab9902025-02-24WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM186ARNICA, FERR. PHOS, IGNATIA, SILICA, HYPERICUMBestmade Natural Products2e9437ae-59fa-c646-e063-6294a90ac0f62025-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM173ECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBestmade Natural Products2e7de086-a4c1-ae9e-e063-6394a90aa5f52025-02-19WarningsExact identifier
unii: ETJ7Z6XBU4
Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.f061d6b1-89f7-4d5f-ac59-9c73408517c12025-02-19WarningsExact identifier
unii: 2S068B75ZU
Bestmade Natural Products BM146ACID SULPH, APIS MELL, ARNICA MONT, CALENDULA OFF, HAMAMELIS, IODIUM, LYCOPODIUM, SILICEABestmade Natural Products2e69161f-e4e2-a5cc-e063-6394a90a476f2025-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens Allegra AllergyFEXOFENADINE HYDROCHLORIDEChattem, Inc.06115cea-5a44-409d-85ed-bb71743491c12025-02-18WarningsExact identifier
application number: NDA021909
ndc (package): 41167-4232-1
ndc (package): 41167-4232-6
ndc (product): 41167-4232
ndc11 (package): 41167423206
rxcui: 997484
rxcui: 997482
spl id: 44cdb5d9-8c36-41e1-af5a-35983ab0cc52
spl set id: 06115cea-5a44-409d-85ed-bb71743491c1
unii: 2S068B75ZU
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Aurum HypericumAURUM HYPERICUMUriel Pharmacy, Inc2df4f968-af1d-82f1-e063-6294a90a65be2025-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEA 6XSILICEASEVENE USAff0e0009-8bbe-e0eb-e053-6294a90afa822025-02-11WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BM127CALC CARB, LYCOPODIUM, SENEGA, SILICEA, STICTA PULM, YERBA SANTABestmade Natural Products2dcc5468-9b11-b6d5-e063-6294a90a41392025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
SILICEA 200ckSILICEASEVENE USAcf89bb22-9e2f-9143-e053-2995a90aff192025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4
Teeth-GumsCHAMOMILLA, ECHINACEA, ACONITUM NAPELLUS, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CALENDULA OFFICINALIS, CHAMOMILLA, CHELIDONIUM MAJUS, CROTALUS HORRIDUS, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, MERCURIUS VIVUS, MYRRHA, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PLANTAGO MAJOR, RHUS TOXICODENDRON, SILICEA, STAPHYSAGRIANewton Laboratories, Inc.9d27b1e4-a966-5495-e053-2a95a90a965b2025-02-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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