ACETIC ACID OTIC SOLUTION USP, 2%

Manufacturer: Morton Grove Pharmaceuticals, Inc.
Effective date: 2019-01-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 20:27:24

Label at a glance#

ProductACETIC ACID

Active ingredientACETIC ACID

Label structure10 sections

Indications and uses

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

Dosage and administration

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Acetic Acid Otic Solution, USP is a nonaqueous solution of glacial acetic acid, USP (2%), in a propylene glycol vehicle containing benzethonium chloride, USP (0.02%); propylene glycol diacetate, NF (3%) and sodium acetate, USP (0.015%). It may also contain citric acid, USP.

The molecular formula for acetic acid is CH₃COOH, with a molecular weight of 60.05. The structural formula is:

Acetic Acid Otic Solution is available as a nonaqueous otic solution buffered at pH 3 for use in the external ear canal.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Acetic acid is anti-bacterial and anti-fungal; propylene glycol is hydrophilic and provides a low surface tension; benzethonium chloride is a surface active agent that promotes contact of the solution with tissues.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

For the treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Hypersensitivity to Acetic Acid Otic Solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.

WARNINGS

WARNINGS SECTION

Discontinue promptly if sensitization or irritation occurs.

PRECAUTIONS

PRECAUTIONS SECTION

Transient stinging or burning may be noted occasionally when the solution is first instilled into the acutely inflamed ear.

Pediatric Use

PEDIATRIC USE SECTION

Safety and Effectiveness in pediatric patients below the age of 3 years have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Stinging or burning may be noted occasionally; local irritation has occurred very rarely.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Carefully remove all cerumen and debris to allow Acetic Acid Otic Solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with the solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 to 5 drops of the solution every 4 to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of Acetic Acid Otic Solution 3 or 4 times daily thereafter, for as long as indicated. In pediatric patients, 3 to 4 drops may be sufficient due to the smaller capacity of the ear canal.

HOW SUPPLIED

HOW SUPPLIED SECTION

Acetic Acid Otic Solution USP, 2% is supplied in 15 mL measured drop, safety-tip plastic bottles.

RECOMMENDED STORAGE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

KEEP CONTAINER TIGHTLY CLOSED

Rx Only

Product No.: 8741

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc

Morton Grove, IL 60053

A50-8741-15

REV. 09-12

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MGP

NDC 60432-741-15

ACETIC ACID

OTIC

SOLUTION

USP, 2%

DO NOT USE IF BAND

PRINTED "SEALED FOR YOUR

PROTECTION" AROUND CAP

IS BROKEN OR MISSING.

Rx Only

NET CONTENTS:

15 mL

MGP

NDC 60432-741-16

ACETIC ACID

OTIC

SOLUTION

USP, 2%

DO NOT USE IF BAND

PRINTED "SEALED FOR YOUR

PROTECTION" AROUND CAP

IS BROKEN OR MISSING.

Rx Only

NET CONTENTS:

15 mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60432-741-15	2025-11-12	C162847	48780-1	f386c649-eb6e-0266-e053-dadaa90a7c1a	ACETIC ACID OTIC SOLUTION USP, 2%
60432-741-16	2025-11-12	C162847	48780-1	f386c649-eb6e-0266-e053-dadaa90a7c1a	ACETIC ACID OTIC SOLUTION USP, 2%
60432-741-15	2023-01-30	C162847	48780-1	f386c649-eb6e-0266-e053-dadaa90a7c1a	ACETIC ACID OTIC SOLUTION USP, 2%
60432-741-16	2023-01-30	C162847	48780-1	f386c649-eb6e-0266-e053-dadaa90a7c1a	ACETIC ACID OTIC SOLUTION USP, 2%

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60432-741	ACETIC ACID SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]	6	Legacy NDC	20190105_c0ec47b7-c13a-4fa0-91fe-d7a03c70aec9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60432-741-15	ML - Milliliter	60432-741	735c6d7f-86d2-45ee-a503-38f67eab1afd	1	2013-02-13
60432-741-16	ML - Milliliter	60432-741	2982a321-5b47-4e6b-903e-5a29f1469c1f	1	2019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
ACETIC ACID	ACTIVE INGREDIENT	Q40Q9N063P	3
ACETIC ACID	ACTIVE MOIETY	Q40Q9N063P	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	3
BENZETHONIUM CHLORIDE	INACTIVE INGREDIENT	PH41D05744	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
PROPYLENE GLYCOL DIACETATE	INACTIVE INGREDIENT	5Z492UNF9O	3
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	3

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

ACETIC ACID
PROPYLENE GLYCOL
PROPYLENE GLYCOL DIACETATE
BENZETHONIUM CHLORIDE
SODIUM ACETATE
ANHYDROUS CITRIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60432-741	60432-741-15, 60432-741-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACETIC ACID	Q40Q9N063P	ACTIB
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLENE GLYCOL DIACETATE	5Z492UNF9O	IACT
BENZETHONIUM CHLORIDE	PH41D05744	IACT
SODIUM ACETATE	4550K0SC9B	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 183 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 32 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	POWDER, FOR SOLUTION / ORAL		123 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION / INTRAMUSCULAR		101 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LIQUID / INTRAVENOUS		18 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.03 %w/v		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	GRANULE, FOR SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SOLUTION / INTRAOCULAR		195 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	POWDER, FOR SOLUTION / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	PASTE / ORAL		26 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LOTION / TOPICAL		211 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION / OPHTHALMIC	0.09 %w/v		Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	LIQUID / INTRAVENOUS	0.2 %w/v		Exact identifier — unii candidate 32 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SOLUTION/ DROPS / AURICULAR (OTIC)	0.03 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZETHONIUM CHLORIDE	BENZETHONIUM CHLORIDE	PH41D05744	CREAM / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SHAMPOO / TOPICAL	0.07 %w/w		Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION / INTRAVENOUS		4239 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	LOZENGE / TRANSMUCOSAL		44 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / SUBLINGUAL		11 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION / INTRADERMAL	1.6 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SOLUTION/ DROPS / OPHTHALMIC	1.24 %w/v		Exact identifier — unii candidate 32 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	ELIXIR / ORAL		90 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		414 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	SOLUTION / INTRAVENOUS		20 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CAPSULE / ORAL		131 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 32 equally ranked IID candidates
SODIUM ACETATE	SODIUM ACETATE	4550K0SC9B	LIQUID / SUBCUTANEOUS	0.2 %w/v		Exact identifier — unii candidate 32 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL DIACETATE	PROPYLENE GLYCOL DIACETATE	5Z492UNF9O	CREAM / TOPICAL	10 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040166-001	ACETIC ACID	ACETIC ACID, GLACIAL	2%	SOLUTION/DROPS / OTIC			1996-07-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC	AT	RS	1996-07-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040166-001	ACETIC ACID	2%	SOLUTION/DROPS / OTIC			1996-07-26	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040166-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040166-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040166-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040166-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040166-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040166-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040166-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040166-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040166-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040166-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040166-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040166-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040166-001	AT	1	`ea99ee380514…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4361634b-bbba-1b0b-e063-6394a90ae2f8			c0ec47b7-c13a-4fa0-91fe-d7a03c70aec9	2025-11-12	Warnings, Adverse reactions	Exact identifier spl set id: c0ec47b7-c13a-4fa0-91fe-d7a03c70aec9

Reported adverse events (FAERS/openFDA)#

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