HylaTears

Product NDC: 72094-001
11-digit product format: 720940001
Labeler code: 72094
Product ID: 72094-001_2b5fc4c4-843d-8d3d-e063-6394a90a5a1b
Type: HUMAN OTC DRUG
Nonproprietary name: Eye Drops
Dosage form: LIQUID
Route: OPHTHALMIC
Labeler: Hyalogic LLC
Application: M014
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-02-12
Substance: HYPROMELLOSE 2910 (4000 MPA.S)
Active strength: 3 mg/10mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72094-001		I	Inactivated by FDA		2026-10-12
excluded package	package	72094-001	72094-001-02	I	Inactivated by FDA		2026-10-12

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 1 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72094-001-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72094-001-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72094-001-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72094-001-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72094-001-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72094-001-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72094-001-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72094-001-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72094-001-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: HylaTears
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYPROMELLOSE 2910 (4000 MPA.S)	3 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RN3152OP35	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2b5fc4c4-843c-8d3d-e063-6394a90a5a1b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
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
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72094-001-02	2025-01-30	C162847	48780-1	d6a99b39-edd8-a426-e053-dadaa90af4c2	Hyalogic Hyla Tears-corrected one of the inactive ingredients-added updated box under principle display panel.
72094-001-01	2022-02-10	C162847	48780-1	d6a99b39-edd8-a426-e053-dadaa90af4c2	Hyalogic Hyla Tears-corrected one of the inactive ingredients-added updated box under principle display panel.
72094-001-01	2022-01-28	C162847	48780-1	d6a99b39-edd8-a426-e053-dadaa90af4c2	Hyalogic Hyla Tears-corrected one of the inactive ingredients-added updated box under principle display panel.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72094-001-01	HylaTears	20 mL in 1 BOTTLE, DROPPER	LIQUID	20	5
72094-001-02	HylaTears	1 in 1 BOX	LIQUID	1	5
72094-001-03	HylaTears	20 mL in 1 BOTTLE, DROPPER	LIQUID	20	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72094-001	HYLATEARS (EYE DROPS) LIQUID [HYALOGIC LLC]	5	Current NDC, Legacy NDC, 2 package rows	20220211_64a30066-79a2-451d-e053-2991aa0ac68c.zip
72094-001	HYLATEARS (EYE DROPS) LIQUID [HYALOGIC LLC]	2	Current NDC, Legacy NDC, 1 package rows	20250123_2b5fc4c4-843c-8d3d-e063-6394a90a5a1b.zip

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 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EAR WAX RMVL Rite Aid	CARBAMIDE PEROXIDE 6.5%	Rite Aid	9e3cedcc-e523-2653-e053-2a95a90ad143	2023-12-15	Warnings	Exact identifier application number: M014
EarWax Removal Kit Rite Aid	CARBAMIDE PEROXIDE 6.5%	Rite Aid	da78ac58-6c1c-4fa9-baac-e9dec0241385	2023-12-15	Warnings	Exact identifier application number: M014
Otix Ear wax Removal System Ear wax and Bulb	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	15868798-28cd-4495-9baf-711e81ad8bdd	2023-12-14	Warnings	Exact identifier application number: M014
Otix Ear wax Removal Drops	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	0e70ab09-9360-4ab6-a1fe-6f82af392581	2023-12-14	Warnings	Exact identifier application number: M014
TopCare Earwax Removal Drops	CARBAMIDE PEROXIDE	Topco Associates LLC	c5b1ad0e-3712-40fd-afbe-54c0b5f1160b	2023-12-14	Warnings	Exact identifier application number: M014
DG Health Earwax Removal kit	CARBAMIDE PEROXIDE 6.5%	DOLLAR GENERAL CORPORATION	4b6fc00f-72d7-4675-9881-b763f27c06e3	2023-12-07	Warnings	Exact identifier application number: M014
Ear Wax Removal Drops Equate	CARBAMIDE PEROXIDE - 6.5%	WALMART STORES INC	33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d	2023-12-04	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Proficient Rx LP	a131447b-a5a0-45cd-a59c-a9f719275baa	2023-12-01	Warnings	Exact identifier application number: M014
Ear Wax Removal Drops	CARBAMIDE PEROXIDE - 6.5%	Sheffield Pharmaceuticals LLC	aad7e2cd-cb28-423c-a441-eabe6516d40f	2022-12-06	Warnings	Exact identifier application number: M014

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RN3152OP35	HYPROMELLOSE 2910 (4000 MPA.S)	9004-65-3	HYPROMELLOSE 2910 (4000 MPA.S)

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72094-001-01	72094000101	20 mL in 1 BOTTLE, DROPPER (72094-001-01)	20 ml	2018-02-12	0000-00-00	No	No	Current
72094-001-02	72094000102	1 BOTTLE, DROPPER in 1 BOX (72094-001-02) > 20 mL in 1 BOTTLE, DROPPER (72094-001-01)		2018-02-12	0000-00-00	No	No	Current
72094-001-03	72094000103	20 mL in 1 BOTTLE, DROPPER (72094-001-03)	20 ml	2018-02-12		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eye Drops - Hyalogic LLC \| Optikem International, Inc.	Hyalogic LLC \| Optikem International, Inc.	2025-01-10	HUMAN OTC DRUG LABEL	2
Eye Drops	Hyalogic LLC \| Regulatory Matters Consulting	2022-02-10	HUMAN OTC DRUG LABEL	5