FLORIL TEARS
- Product NDC
- 16995-004
- 11-digit product format
- 169950004
- Labeler code
- 16995
- Product ID
- 16995-004_94f2f212-eba2-47a6-96ac-9f9639e2a09d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- POLYVINYL ALCOHOL
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- VITALINE S.A.C.
- Application
- part349
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2005-11-10
- Marketing end
- 0000-00-00
- Substance
- POLYVINYL ALCOHOL
- Active strength
- 14 mg/mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 16995-004-01 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c6a8-621f-e053-dbdaa90a74ad | 8101c006-0b47-4484-8760-a959764f555c |
| 16995-004-02 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c6a8-621f-e053-dbdaa90a74ad | 8101c006-0b47-4484-8760-a959764f555c |
| 16995-004-03 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c6a8-621f-e053-dbdaa90a74ad | 8101c006-0b47-4484-8760-a959764f555c |
| 16995-004-04 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c6a8-621f-e053-dbdaa90a74ad | 8101c006-0b47-4484-8760-a959764f555c |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 16995-004-01 | FLORIL TEARS | 3 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 3 | 1 | |
| 16995-004-02 | FLORIL TEARS | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 1 | |
| 16995-004-03 | FLORIL TEARS | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 1 | |
| 16995-004-04 | FLORIL TEARS | 30 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 30 | 1 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| POLYVINYL ALCOHOL | ACTIVE INGREDIENT | 532B59J990 | FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.] | 1 | |
| POLYVINYL ALCOHOL | ACTIVE MOIETY | 532B59J990 | FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.] | 1 | |
| POLYETHYLENE GLYCOL 300 | INACTIVE INGREDIENT | 5655G9Y8AQ | FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1039907 | Floril TEARS 0.2 % / 1.4 % Ophthalmic Solution | PSN | 8101c006-0b47-4484-8760-a959764f555c | 1 |
| 1039905 | polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic Solution | PSN | 8101c006-0b47-4484-8760-a959764f555c | 1 |
| 1039907 | polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution [Floril Tears] | SBD | 8101c006-0b47-4484-8760-a959764f555c | 1 |
| 1039905 | polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution | SCD | 8101c006-0b47-4484-8760-a959764f555c | 1 |
| 1039907 | Floril Tears (polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % ) Ophthalmic Solution | SY | 8101c006-0b47-4484-8760-a959764f555c | 1 |
| 1039907 | Floril Tears (polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML) Ophthalmic Solution | SY | 8101c006-0b47-4484-8760-a959764f555c | 1 |
| 1039905 | polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic Solution | SY | 8101c006-0b47-4484-8760-a959764f555c | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 16995-004-01 | 16995000401 | 3 mL in 1 BOTTLE, DROPPER | 3 ml | Historical |
| 16995-004-02 | 16995000402 | 10 mL in 1 BOTTLE, DROPPER | 10 ml | Historical |
| 16995-004-03 | 16995000403 | 15 mL in 1 BOTTLE, DROPPER | 15 ml | Historical |
| 16995-004-04 | 16995000404 | 30 mL in 1 BOTTLE, DROPPER | 30 ml | Historical |