HylaTears
- Product NDC
- 72094-001
- Requested package NDC
- 72094-001-01
- 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
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 |
|---|---|
| HYPROMELLOSE 2910 (4000 MPA.S) | 3 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RN3152OP35 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2b5fc4c4-843c-8d3d-e063-6394a90a5a1b | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| 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 | Form | Quantity | Strength | 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 | 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.
| 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 | M014 |
| EarWax Removal Kit Rite Aid | CARBAMIDE PEROXIDE 6.5% | Rite Aid | da78ac58-6c1c-4fa9-baac-e9dec0241385 | 2023-12-15 | Warnings | M014 |
| Otix Ear wax Removal System Ear wax and Bulb | CARBAMIDE PEROXIDE | Bell Pharmaceuticals, Inc. | 15868798-28cd-4495-9baf-711e81ad8bdd | 2023-12-14 | Warnings | M014 |
| Otix Ear wax Removal Drops | CARBAMIDE PEROXIDE | Bell Pharmaceuticals, Inc. | 0e70ab09-9360-4ab6-a1fe-6f82af392581 | 2023-12-14 | Warnings | M014 |
| TopCare Earwax Removal Drops | CARBAMIDE PEROXIDE | Topco Associates LLC | c5b1ad0e-3712-40fd-afbe-54c0b5f1160b | 2023-12-14 | Warnings | M014 |
| DG Health Earwax Removal kit | CARBAMIDE PEROXIDE 6.5% | DOLLAR GENERAL CORPORATION | 4b6fc00f-72d7-4675-9881-b763f27c06e3 | 2023-12-07 | Warnings | M014 |
| Ear Wax Removal Drops Equate | CARBAMIDE PEROXIDE - 6.5% | WALMART STORES INC | 33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d | 2023-12-04 | Warnings | M014 |
| Good Neighbor Pharmacy Earwax Removal Drops | CARBAMIDE PEROXIDE | Proficient Rx LP | a131447b-a5a0-45cd-a59c-a9f719275baa | 2023-12-01 | Warnings | M014 |
| Ear Wax Removal Drops | CARBAMIDE PEROXIDE - 6.5% | Sheffield Pharmaceuticals LLC | aad7e2cd-cb28-423c-a441-eabe6516d40f | 2022-12-06 | Warnings | M014 |
Packages#
| 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 |