Aerowash Eyewash and Skin-Rinse

Product NDC: 55305-112
11-digit product format: 553050112
Labeler code: 55305
Product ID: 55305-112_6e120024-473b-73af-e053-2a91aa0a42a6
Type: HUMAN OTC DRUG
Nonproprietary name: purified water
Dosage form: SOLUTION
Route: OPHTHALMIC
Labeler: Aero Healthcare
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-05-01
Marketing end: 0000-00-00
Substance: WATER
Active strength: 99 mL/100mL
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55305-112		I	Inactivated by FDA	2026-10-05
excluded package	package	55305-112	55305-112-12	I	Inactivated by FDA	2026-10-05
excluded package	package	55305-112	55305-112-13	I	Inactivated by FDA	2026-10-05
excluded package	package	55305-112	55305-112-14	I	Inactivated by FDA	2026-10-05
excluded package	package	55305-112	55305-112-15	I	Inactivated by FDA	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 105 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55305-112-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55305-112-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55305-112-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55305-112-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55305-112-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55305-112-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55305-112-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55305-112-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55305-112-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55305-112-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55305-112-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55305-112-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55305-112-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55305-112-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55305-112-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55305-112-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55305-112-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55305-112-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55305-112-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55305-112-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55305-112-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55305-112-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55305-112-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55305-112-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55305-112-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55305-112-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55305-112-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55305-112-13	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55305-112-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55305-112-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55305-112-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55305-112-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55305-112-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55305-112-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55305-112-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55305-112-13	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55305-112-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55305-112-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55305-112-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55305-112-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55305-112-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55305-112-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55305-112-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55305-112-13	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55305-112-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55305-112-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55305-112-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55305-112-13	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
55305-112-12	AEROWASH EYEWASH
55305-112-13	AEROWASH EYEWASH
55305-112-14	AEROWASH EYEWASH
55305-112-15	AEROWASH EYEWASH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55305-112-10	Aerocool Cold Spray	113 g in 1 BOTTLE, SPRAY		113	2
55305-112-12	Aerowash Eyewash and Skin-Rinse	148 mL in 1 BOTTLE, PLASTIC	SOLUTION	148	2
55305-112-13	Aerowash Eyewash and Skin-Rinse	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473	2
55305-112-14	Aerowash Eyewash and Skin-Rinse	15 mL in 1 VIAL, SINGLE-USE	SOLUTION	15	2
55305-112-15	Aerowash Eyewash and Skin-Rinse	947 mL in 1 BOTTLE, PLASTIC	SOLUTION	947	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WATER	ACTIVE INGREDIENT	059QF0KO0R	AEROWASH EYEWASH AND SKIN-RINSE (PURIFIED WATER) SOLUTION [AERO HEALTHCARE]	1
WATER	ACTIVE MOIETY	059QF0KO0R	AEROWASH EYEWASH AND SKIN-RINSE (PURIFIED WATER) SOLUTION [AERO HEALTHCARE]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	AEROWASH EYEWASH AND SKIN-RINSE (PURIFIED WATER) SOLUTION [AERO HEALTHCARE]	1
POLIHEXANIDE	INACTIVE INGREDIENT	322U039GMF	AEROWASH EYEWASH AND SKIN-RINSE (PURIFIED WATER) SOLUTION [AERO HEALTHCARE]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	AEROWASH EYEWASH AND SKIN-RINSE (PURIFIED WATER) SOLUTION [AERO HEALTHCARE]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	AEROWASH EYEWASH AND SKIN-RINSE (PURIFIED WATER) SOLUTION [AERO HEALTHCARE]	1
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE	INACTIVE INGREDIENT	E1W4N241FO	AEROWASH EYEWASH AND SKIN-RINSE (PURIFIED WATER) SOLUTION [AERO HEALTHCARE]	1
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	INACTIVE INGREDIENT	5QWK665956	AEROWASH EYEWASH AND SKIN-RINSE (PURIFIED WATER) SOLUTION [AERO HEALTHCARE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55305-112	AEROCOOL COLD SPRAY () [AERO HEALTHCARE, LLC.]	2	Legacy NDC, 1 package rows	20140820_53f81868-2efd-4cb2-bd47-97ee73cdbf89.zip
55305-112	AEROWASH EYEWASH AND SKIN-RINSE (PURIFIED WATER) SOLUTION [AERO HEALTHCARE]	2	Legacy NDC, 4 package rows	20180608_491f8433-bcf2-4545-8974-3094fa5b4a29.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
059QF0KO0R	WATER	7732-18-5	WATER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1423321	water 98.5 % Ophthalmic Irrigation Solution	PSN	491f8433-bcf2-4545-8974-3094fa5b4a29	2
1423321	water 985 MG/ML Ophthalmic Irrigation Solution	SCD	491f8433-bcf2-4545-8974-3094fa5b4a29	2
1423321	water 98.5 % Ophthalmic Irrigation Solution	SY	491f8433-bcf2-4545-8974-3094fa5b4a29	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
55305-112-10	55305011210	113 g in 1 BOTTLE, SPRAY	113 g	Historical
55305-112-12	55305011212	148 mL in 1 BOTTLE, PLASTIC	148 ml	Historical
55305-112-13	55305011213	473 mL in 1 BOTTLE, PLASTIC	473 ml	Historical
55305-112-14	55305011214	15 mL in 1 VIAL, SINGLE-USE	15 ml	Historical
55305-112-15	55305011215	947 mL in 1 BOTTLE, PLASTIC	947 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AEROWASH EYEWASH	Aero Healthcare	2018-06-07	HUMAN OTC DRUG LABEL	2
Aerocool Topical Skin Refrigerant Cold Spray	Aero Healthcare, LLC.	2014-08-20	OTC MEDICAL DEVICE LABEL	2