FDA.reportPublic FDA data

acetic acid 2 % / hydrocortisone 1 % Otic Solution

RxCUI
313786
RxNorm name
acetic acid 2 % / hydrocortisone 1 % Otic Solution
Display name
acetic acid 2 % / hydrocortisone 1 % Otic Solution
Full name
acetic acid 2 % / hydrocortisone 1 % Otic Solution
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:30

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hydrocortisone and acetic acidHYDROCORTISONE AND ACETIC ACID OTICSaptalis Pharmaceuticals, LLCd9a3597c-2c9d-46cc-818b-8bb3aa5c4f322025-04-25Warnings, Adverse reactionsExact identifier
rxcui: 313786
hydrocortisone and acetic acidHYDROCORTISONE AND ACETIC ACIDCosette Pharmaceuticals, Inc.cef3713f-11f3-4723-9267-3d79855b49bf2024-02-02Warnings, Adverse reactionsExact identifier
rxcui: 313786

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ffd1edc1-2f40-4b0a-a53a-9fb53b8d3184acetic acid 2 % / hydrocortisone 1 % Otic Solution [PSN] · acetic acid 20 MG/ML / hydrocortisone 10 MG/ML Otic Solution [SCD] · acetic acid 2 % / hydrocortisone 1 % Otic Solution [SY]36Hydrocortisone and Acetic Acid Otic Solution, USP20221013
d9a3597c-2c9d-46cc-818b-8bb3aa5c4f32acetic acid 2 % / hydrocortisone 1 % Otic Solution [PSN] · acetic acid 20 MG/ML / hydrocortisone 10 MG/ML Otic Solution [SCD] · acetic acid 2 % / hydrocortisone 1 % Otic Solution [SY]33Hydrocortisone and Acetic Acid Otic Solution, USP Rx only20250425
cef3713f-11f3-4723-9267-3d79855b49bfacetic acid 2 % / hydrocortisone 1 % Otic Solution [PSN] · acetic acid 20 MG/ML / hydrocortisone 10 MG/ML Otic Solution [SCD] · acetic acid 2 % / hydrocortisone 1 % Otic Solution [SY]31Hydrocortisone and Acetic Acid Otic Solution, USP Rx only20240202