MedPath

Acetic acid

Generic Name
Acetic acid
Brand Names
Fem Ph, Naturalyte, Relagard, Selectbag One
Drug Type
Small Molecule
Chemical Formula
C2H4O2
CAS Number
64-19-7
Unique Ingredient Identifier
Q40Q9N063P

Overview

Acetic acid is a product of the oxidation of ethanol and of the destructive distillation of wood. It is used locally, occasionally internally, as a counterirritant and also as a reagent. (Stedman, 26th ed) Acetic acid otic (for the ear) is an antibiotic that treats infections caused by bacteria or fungus.

Indication

Used to treat infections in the ear canal.

Associated Conditions

  • Acute Otitis Externa
  • External ear infection NOS
  • Infection

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Cantrell Drug Company
52533-105
INTRAVENOUS
N/A
12/11/2014
NuCare Pharmaceuticals,Inc.
68071-1739
AURICULAR (OTIC)
20.65 mg in 1 mL
2/22/2021
Akorn Operating Company LLC
50383-901
AURICULAR (OTIC)
20.75 mg in 1 mL
10/13/2022
Unit Dose Services
50436-4600
AURICULAR (OTIC)
20 mg in 1 mL
8/15/2017
NuCare Pharmaceuticals,Inc.
68071-2984
AURICULAR (OTIC)
20.65 mg in 1 mL
4/19/2023
Baxter Healthcare Corporation
0338-0656
IRRIGATION
250 mg in 100 mL
4/15/2015
Pharmics, Inc.
0813-0799
VAGINAL
0.009 g in 1 g
1/18/2023
ICU Medical Inc.
0990-6143
IRRIGATION
250 mg in 100 mL
6/17/2020
King Bio Inc.
57955-9001
ORAL
10 [hp_X] in 59 mL
5/19/2025
Cantrell Drug Company
52533-233
INTRAVENOUS
N/A
3/18/2016

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
TANA CORN AND WART SOLVENT
N/A
N/A
N/A
8/22/1989

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
ACI-JEL BALANCE Gel tube
13282
Medicine
A
8/28/1991
EARCLEAR SWIMMER'S EAR drops bottle
50555
Medicine
A
1/5/1995
Aquaear Ear Drops solution bottle
13857
Medicine
A
8/30/1991

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ACID CONCENTRATE RZ119C
genpharm ulc
N/A
Liquid - Haemodialysis
10.81 G / L
12/31/1995
ACID CONCENTRATE RO4137
genpharm ulc
N/A
Liquid - Haemodialysis
6.635 G / L
12/31/1995
ACID CONCENTRATE D-18003
baxter corporation
02158132
Liquid - Haemodialysis
6.31 G / L
12/31/1995
ACID CONCENTRATE D12303
althin biopharm inc.
02217627
Liquid - Haemodialysis
10.8 G / L
12/31/1996
ACID CONCENTRATE RZ254C
genpharm ulc
02178389
Liquid - Haemodialysis
10.81 G / L
12/31/1995
SELECTBAG ONE (AX 450 G)
Vantive ULC
02415488
Solution - Haemodialysis
36 G / L
4/21/2017
SB 1000
renal systems, division of minntech corp.
00678783
Liquid - Haemodialysis
8.8 G / L
12/31/1985
ACID CONCENTRATE A1280
chief medical supplies ltd
02272636
Solution - Haemodialysis
10.81 G / L
N/A
ACID CONCENTRATE A1275
chief medical supplies ltd
02272563
Solution - Haemodialysis
10.81 G / L
11/6/2015
ACID CONCENTRATE A1230
chief medical supplies ltd
02254085
Solution - Haemodialysis
10.81 G / L
8/17/2005

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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