FDA.reportPublic FDA data

NDC 51672-2141-01 - Childrens Fexofenadine Hydrochloride 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
51672-2141
Requested NDC
51672-2141-01
Package NDCs from labels
51672-2141-8, 51672-2141-1, 51672-2141-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Children's Fexofenadine Hcl AllergySun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-08-11HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
51672-2141-1Children's Fexofenadine Hcl Allergy
51672-2141-1Children's Fexofenadine Hcl Allergy
51672-2141-8Children's Fexofenadine Hcl Allergy
51672-2141-8Children's Fexofenadine Hcl Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2141-1Childrens Fexofenadine HydrochlorideAllergy1 in 1 CARTONSUSPENSION15
51672-2141-1Childrens Fexofenadine HydrochlorideAllergy240 mL in 1 BOTTLESUSPENSION2405
51672-2141-8Childrens Fexofenadine HydrochlorideAllergy120 mL in 1 BOTTLESUSPENSION1205
51672-2141-8Childrens Fexofenadine HydrochlorideAllergy1 in 1 CARTONSUSPENSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2141CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY (FEXOFENADINE HYDROCHLORIDE) SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, 4 package rows20240130_b21bb11d-bf74-4ee7-9cfe-5b599a3c4775.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2141-8ML - Milliliter51672-21417cefccf4-e5bd-46d0-9216-72503db9705012026-04-20

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 2 of 134 · 2,676 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
CALMS FORTEAVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWERHyland's Inc.63ce9942-a299-4d9b-b63b-35b297472dc92026-08-13WarningsExact identifier
unii: 70WT22SF4B
Childrens AllergyFEXOFENADINE HCLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)667c87c2-c594-49e5-92a7-f8aa140642d62026-08-12WarningsExact identifier
rxcui: 997491
unii: 2S068B75ZU
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Childrens Fexofenadine Hydrochloride AllergyFEXOFENADINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.b21bb11d-bf74-4ee7-9cfe-5b599a3c47752026-08-11WarningsExact identifier
application number: ANDA208123
ndc (package): 51672-2141-8
ndc (package): 51672-2141-1
ndc (product): 51672-2141
ndc11 (package): 51672214101
rxcui: 997491
spl id: 58cbdd55-848f-51c5-e063-6294a90aaa53
spl set id: b21bb11d-bf74-4ee7-9cfe-5b599a3c4775
unii: 2S068B75ZU
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLC5413d84e-f945-4920-8981-f62978f21d672026-08-06WarningsExact identifier
unii: 2S068B75ZU
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLC683cb2ea-c913-48f4-8adc-2888da3b655e2026-08-06WarningsExact identifier
unii: 2S068B75ZU
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Fexofenadine HydrochlorideFEXOFENADINE HYDROCHLORIDEAurohealth LLCeb8e67dc-e2df-4c35-bfd7-12af67e1354a2026-08-06WarningsExact identifier
unii: 2S068B75ZU
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
dg health aller easeFEXOFENADINE HYDROCHLORIDEDolgencorp Incf9239aa4-b3d0-4817-b639-61ad1383f7072026-08-05WarningsExact identifier
unii: 2S068B75ZU
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
LEADER 12HR ALLERGY AND CONGESTION RELIEFFEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leader1400014a-2fa6-4a4f-8eb9-85ac049b4b702026-08-03WarningsExact identifier
unii: 2S068B75ZU

Reported adverse events (FAERS/openFDA)#

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