Sunmark Eye Drops Advanced Moisturizer/Lubricant
- Product NDC
- 49348-697
- 11-digit product format
- 493480697
- Labeler code
- 49348
- Product ID
- 49348-697_0d2942e7-fe3a-4dd4-e063-6394a90a020f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextran, Polyethylene glycol 400, Povidone, Tetrahydrozoline
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Strategic Sourcing Services LLC
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2007-03-01
- Substance
- DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
- Active strength
- .1; 1; 1; .05 g/100mL; g/100mL; g/100mL; g/100mL
- Pharmacologic classes
- Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
- 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
- Sunmark Eye Drops Advanced Moisturizer/Lubricant
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTRAN 70 | .1 g/100mL |
| POLYETHYLENE GLYCOL 400 | 1 g/100mL |
| POVIDONE | 1 g/100mL |
| TETRAHYDROZOLINE HYDROCHLORIDE | .05 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 7SA290YK68 | Internal UNII lookup |
| B697894SGQ | Internal UNII lookup |
| FZ989GH94E | Internal UNII lookup |
| 0YZT43HS7D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 996202 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0daa4e39-0447-44b6-a7d7-370b12bf9451 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49348-697-29 | Sunmark Eye Drops Advanced Moisturizer/Lubricant | 15 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 15 | 4 | |
| 49348-697-29 | Sunmark Eye Drops Advanced Moisturizer/Lubricant | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49348-697-29 | ML - Milliliter | 49348-697 | f8d6a35b-849c-43d7-a8df-3a23def9cd2c | 1 | 2014-10-03 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49348-697 | SUNMARK EYE DROPS ADVANCED MOISTURIZER/LUBRICANT (DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE) SOLUTION/ DROPS [STRATEGIC SOURCING SERVICES LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240104_0daa4e39-0447-44b6-a7d7-370b12bf9451.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 |
|---|---|---|---|---|---|---|
| HEB Advanced Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | HEB Grocery Company, LP | f76281d6-3aea-349b-e053-6394a90afca2 | 2023-12-20 | Warnings | M018 |
| Equaline Eye Drops A.C. | TETRAHYDROZOLINE HCL, ZINC SULFATE | United Natural Foods, Inc. | f5f894f0-1ab0-4cad-e053-2995a90a7cba | 2023-12-20 | Warnings | M018 |
| Cleareyes Redness Relief | NAPHAZOLINE HYDROCHLORIDE AND GLYCERIN | Lil' Drug Store Products, Inc. | 39e4ab2b-ae12-4339-b219-109cf0f7f06a | 2023-12-15 | Warnings | M018 |
| GenTeal Tears (Moderate) | DEXTRAN 70, GLYCERIN, HYPROMELLOSE | Alcon Laboratories, Inc. | a2992597-3490-6a5c-be45-2b6fa15e1547 | 2023-12-15 | Warnings | M018 |
| SYSTANE HYDRATION PF PRESERVATIVE FREE | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | db3a6c68-320b-46b0-83fa-6c29297a84a6 | 2023-12-15 | Warnings | M018 |
| Systane | POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL | Alcon Research Ltd | 14916d2c-a63d-491e-bd91-a61f300af38a | 2023-12-15 | Warnings | M018 |
| Systane | HYPROMELLOSE | Alcon Laboratories, Inc. | 5f74b161-ae41-d0e2-6ed9-8deca55d2c0f | 2023-12-15 | Warnings | M018 |
| Systane Day and Night Value Pack | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3% | Alcon Laboratories, Inc. | df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07 | 2023-12-15 | Warnings | M018 |
| Systane Lubricant | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 15bc06ec-f3dc-3180-ca1a-106769a770ea | 2023-12-15 | Warnings | M018 |
| Systane ULTRA | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | a5c1c194-3db5-4f18-9cd1-97f7f84c3cff | 2023-12-15 | Warnings | M018 |
| Systane COMPLETE PF | PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 7eaa93ca-c843-4c89-921b-c76659410dce | 2023-12-14 | Warnings | M018 |
| BION TEARS | DEXTRAN, HYPROMELLOSE | Alcon Laboratories, Inc. | e48d82f0-2f18-e514-4caa-e397d6713b99 | 2023-12-14 | Warnings | M018 |
| GenTeal Tears Severe | HYPROMELLOSE | Alcon Laboratories, Inc. | a57854fc-f3a2-4fbb-b718-cd06f87a721e | 2023-12-14 | Warnings | M018 |
| BION TEARS | DEXTRAN, HYPROMELLOSE | Alcon Laboratories, Inc. | 538c2a89-efb5-4132-b678-5a78f23cb713 | 2023-12-14 | Warnings | M018 |
| GenTeal Tears Gel Drops | POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL | Alcon Laboratories, Inc. | 84388a75-9d11-48ce-bf5a-88f0580d2d03 | 2023-12-14 | Warnings | M018 |
| Alcon Tears Lubricant Eye Drops | HYPROMELLOSE 2910 | Alcon Laboratories, Inc. | 89302e2b-882b-48d5-8df7-be37859b48ba | 2023-12-14 | Warnings | M018 |
| GenTeal Tears Moderate Preservative Free | DEXTRAN 70, HYPROMELLOSE 2910 | Alcon Laboratories, Inc. | 37686e54-e64d-47c8-b082-b944a23cf6f1 | 2023-12-14 | Warnings | M018 |
| Altachlore Sodium Chloride Hypertonicity | SODIUM CHLORIDE | Altaire Pharmaceuticals Inc. | dc0d94d8-4475-4956-8ded-bdb9496074e4 | 2023-12-09 | Warnings | M018 |
| Altalube | MINERAL OIL AND PETROLATUM | Altaire Pharmaceuticals Inc. | eb65004c-c3a7-4079-bd75-f2857d30c68a | 2023-12-09 | Warnings | M018 |
| Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops | POLYVINYL ALCOHOL, POVIDONE | Proficient Rx LP | 73e12596-6dd5-4cd2-83ed-992e1211b4b8 | 2023-12-01 | Warnings | M018 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 996202 | dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic Solution | PSN | 0daa4e39-0447-44b6-a7d7-370b12bf9451 | 4 |
| 996202 | dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution | SCD | 0daa4e39-0447-44b6-a7d7-370b12bf9451 | 4 |
| 996202 | dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic Solution | SY | 0daa4e39-0447-44b6-a7d7-370b12bf9451 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49348-697-29 | 49348069729 | 1 BOTTLE, PLASTIC in 1 CARTON (49348-697-29) / 15 mL in 1 BOTTLE, PLASTIC | 2007-03-01 | 0000-00-00 | No | No | Current |