FDA.reportPublic FDA data

ALEROFF

Manufacturer
OKSALUD COLOMBIA S A S
Effective date
2021-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:14:28

Label at a glance#

ProductALEROFF
Active ingredientHISTAMINE
Label structure10 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

WarningsWarnings

INACTIVE INGREDIENT SECTION

inactiveinactive

DOSAGE & ADMINISTRATION SECTION

directionsdirections

TROUBLESHOOTING

questionsquestions

INFORMATION FOR PATIENTS SECTION

traditional homeopatic practicetraditional homeopatic practice

OTC - ACTIVE INGREDIENT SECTION

activeactive

OTC - PURPOSE SECTION

pruposeprupose

INDICATIONS & USAGE SECTION

USESUSES

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUTKEEP OUT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

frontfront

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81701-111-012024-01-30C16284748780-1e4f33bdf-9c24-d8a0-e053-dadaa90a6e4ebe4d907f-13ca-93a6-e053-2995a90af8b9
81701-111-012022-12-23C16284748780-1e4f33bdf-9c24-d8a0-e053-dadaa90a6e4ebe4d907f-13ca-93a6-e053-2995a90af8b9
81701-111-012022-07-29C16284748780-1e4f33bdf-9c24-d8a0-e053-dadaa90a6e4ebe4d907f-13ca-93a6-e053-2995a90af8b9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81701-111-01ALEROFF30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81701-111ALEROFF (HISTAMINE) LIQUID [OKSALUD COLOMBIA S A S]1Legacy NDC, 1 package rows20210326_be4d907f-13ca-93a6-e053-2995a90af8b9.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81701-11181701-111-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
TUSSILAGO FARFARA FLOWERUEE27X2Q2MIACT
ALCOHOL3K9958V90MIACT
CALADIUM BICOLOR WHOLE66BMR064Z9IACT
RANUNCULUS BULBOSUS ROOTXV11P9Y1A1IACT
URTICA DIOICA710FLW4U46IACT
HISTAMINE820484N8I3ACTIB
SOLANUM LYCOPERSICUM WHOLE0243Q4990LIACT

Source Document#

Source XML

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
be4d907f-13cb-93a6-e053-2995a90af8b9be4d907f-13ca-93a6-e053-2995a90af8b92021-03-24WarningsExact identifier
spl id: be4d907f-13cb-93a6-e053-2995a90af8b9
spl set id: be4d907f-13ca-93a6-e053-2995a90af8b9

Reported adverse events (FAERS/openFDA)#

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