FDA.reportPublic FDA data

NDC 63672-0021-09 - Tamsulosin hydrochloride

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
63672-0021
Requested NDC
63672-0021-09
Package NDCs from labels
63672-0021-0, 63672-0021-9, 63672-0021-09
Manufacturer
Synthon Pharmaceuticals, Inc.
Effective date
2025-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tamsulosin hydrochloride - Synthon Pharmaceuticals, Inc.Synthon Pharmaceuticals, Inc.2025-12-01HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63672-0021-02023-11-02C16284748780-1956f9ecf-d82a-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE capsules. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997
63672-0021-02019-10-21C16284748780-1956f9ecf-d82a-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use TAMSULOSIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TAMSULOSIN HYDROCHLORIDE capsules. TAMSULOSIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63672-0021-0Tamsulosin hydrochloride20200 in 1 DRUMCAPSULE202007
63672-0021-9Tamsulosin hydrochloride20000 in 1 DRUMCAPSULE200007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63672-0021TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20250426_13a5032d-0be1-4001-916e-459f0b1a051d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
tamsulosin hydrochlorideACTIVE INGREDIENT11SV1951MRTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
tamsulosinACTIVE MOIETYG3P28OML5ITAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
shellacINACTIVE INGREDIENT46N107B71OTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RTAMSULOSIN HYDROCHLORIDE CAPSULE [SYNTHON PHARMACEUTICALS, INC.]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 293 · 5,857 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5af9f31b-0c92-e3a9-e063-6394a90a38c92026-09-08WarningsExact identifier
unii: ND2M416302
VerifineALCOHOL SWABSPromisemed Hangzhou Meditech Co., LTD5afc0201-490e-ccf3-e063-6394a90aadad2026-09-08WarningsExact identifier
unii: ND2M416302
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
unii: ND2M416302
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cbbe72-24ec-2e4a-e063-6394a90abbd22026-09-07WarningsExact identifier
unii: ND2M416302
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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