FDA.reportPublic FDA data

NDC 69238-1637-03 - Aminocaproic acid

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
69238-1637
Requested NDC
69238-1637-03
Package NDCs from labels
69238-1637-3, 69238-1637-03
Manufacturer
Major Pharmaceuticals
Effective date
2026-08-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aminocaproic acid - Major PharmaceuticalsMajor Pharmaceuticals2026-08-04HUMAN PRESCRIPTION DRUG LABEL
Aminocaproic Acid Tablets, USP (500 mg) Rx onlyAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC | Amneal Pharmaceuticals Private Limited2026-07-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1637-3Aminocaproic acid30 in 1 BOTTLE, PLASTICTABLET308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1637AMINOCAPROIC ACID TABLET [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, Legacy NDC, 1 package rows20231229_4a22e559-2dac-42d7-af8d-eb0ebbc2f76d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1637-3EA - Each69238-163710343005-a42a-4c5b-804f-4154d27de9c812021-04-08

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 5 · 89 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
Aminocaproic acidAMINOCAPROIC ACIDMajor Pharmaceuticals2612ee97-1723-40f2-99e6-3a736f63200f2026-08-04Warnings, Adverse reactionsExact identifier
application number: ANDA212492
ndc (package): 0904-7165-07
ndc (product): 0904-7165
rxcui: 197351
spl id: 52582352-b804-4329-bf74-d5297fb778db
spl set id: 2612ee97-1723-40f2-99e6-3a736f63200f
unii: U6F3787206
Aminocaproic acidAMINOCAPROIC ACIDAmneal Pharmaceuticals LLC4a22e559-2dac-42d7-af8d-eb0ebbc2f76d2026-07-28Warnings, Adverse reactionsExact identifier
application number: ANDA212492
ndc (package): 69238-1637-3
ndc (product): 69238-1637
ndc11 (package): 69238163703
rxcui: 197351
spl id: 196a0cc5-2750-45d2-8e67-f806e72a5932
spl set id: 4a22e559-2dac-42d7-af8d-eb0ebbc2f76d
unii: U6F3787206
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
AMINOCAPROIC ACIDAMINOCAPROIC ACIDBryant Ranch Prepackc2144bf8-1a26-4958-ba10-5358bd69cd232026-05-19Warnings, Adverse reactionsExact identifier
unii: U6F3787206
Aminocaproic AcidAMINOCAPROIC ACIDHospira, Inc.1c5bc1dd-e9ec-44c1-9281-67ad482315d92026-04-30Warnings, Adverse reactionsExact identifier
unii: U6F3787206
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
Aminocaproic acidAMINOCAPROIC ACIDBPI LABS LLCcfa601c4-b649-417e-a301-b246f080f1eb2026-01-05Warnings, Adverse reactionsExact identifier
unii: U6F3787206

Reported adverse events (FAERS/openFDA)#

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