FDA.reportPublic FDA data

NDC 71838-0010-1 - AMINO EX 500mL

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
71838-0010
Requested NDC
71838-0010-1
Package NDCs from labels
71838-0010-1, 71838-0010-2
Manufacturer
Kwang Duk Sin Yak Co., Ltd.
Effective date
2020-06-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMINO EX 500mL - Kwang Duk Sin Yak Co., Ltd.Kwang Duk Sin Yak Co., Ltd.2020-06-09HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71838-0010-22022-01-28C16284748780-1d6a99b39-3f4e-a426-e053-dadaa90af4c2a7a03fe3-c1a5-5fae-e053-2a95a90ad69d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71838-0010-1AMINO EX500mL500 mL in 1 BOTTLE, PUMPSHAMPOO5001
71838-0010-2AMINO EX500mL1 in 1 CARTONSHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71838-0010AMINO EX 500ML (SALICYLIC ACID) SHAMPOO [KWANG DUK SIN YAK CO., LTD.]1Legacy NDC, 2 package rows20200609_a7a03fe3-c1a5-5fae-e053-2a95a90ad69d.zip

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 84 of 84 · 1,674 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: O414PZ4LPZ
XALIXSALICYLIC ACIDKMM Pharmaceuticals, LLC5c60df47-58cf-5226-e053-2a91aa0a16462017-10-25Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Cleansing WipesSALICYLIC ACIDNextcell Medicale0ad155f-8afb-42ba-a2c3-c10f275612012017-07-28WarningsExact identifier
unii: O414PZ4LPZ
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
SKINPHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASKSALICYLIC ACIDCVS Health03bbb445-4c6b-4f54-bd95-9f5764eae4e42017-03-14WarningsExact identifier
unii: O414PZ4LPZ
SKINPHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACIDSALICYLIC ACIDCVS Health534cebb1-1c69-44b0-8407-e5863d7eaa312017-03-14WarningsExact identifier
unii: O414PZ4LPZ
SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSERSALICYLIC ACIDCVS Health682e43d2-3d85-4ac6-a38c-f39c0f0785732017-02-23WarningsExact identifier
unii: O414PZ4LPZ
SKIN PHARMACY ADVANCED ACNE THERAPY CLARIFYING DAILY CLEANSERSALICYLIC ACIDAMCOL Health & Beauty Solutions, Inc. DBAfc67c24b-9f7f-4475-8e30-fe75851fe31a2016-09-13WarningsExact identifier
unii: O414PZ4LPZ
SKIN PHARMACY ADVANCED ACNE THERAPY OVERNIGHT SALICYLIC ACIDSALICYLIC ACIDAMCOL Health & Beauty Solutions, Inc. DBA4effc518-e869-4d10-aac1-82dc338e28b82016-06-11WarningsExact identifier
unii: O414PZ4LPZ
SKIN PHARMACY ADVANCED ACNE THERAPY PORE REFINING FACIAL MASKSALICYLIC ACIDAMCOL Health & Beauty Solutions, Inc. DBAbae0d24a-711b-4b08-8330-feb2c01fabfd2016-06-11WarningsExact identifier
unii: O414PZ4LPZ
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MG217 PsoriasisSALICYLIC ACIDWisconsin Pharmacal Company2d2c2ab3-7c9e-1d09-e054-00144ff8d46c2016-03-03WarningsExact identifier
unii: O414PZ4LPZ
SKIN MEDICA Purifying Foaming WashSALICYLIC ACIDAllergan, Inc.064d9e2b-077f-4229-b653-666fc5479ae22013-03-01WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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