Systane Balance
- Product NDC
- 0065-1433
- 11-digit product format
- 000651433
- Labeler code
- 0065
- Product ID
- 0065-1433_f81c8282-0871-46fb-8124-83666457a4f2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- propylene glycol
- Dosage form
- EMULSION
- Route
- OPHTHALMIC
- Labeler
- Alcon Laboratories, Inc.
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-06-25
- Substance
- PROPYLENE GLYCOL
- Active strength
- .06 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Systane Balance
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PROPYLENE GLYCOL | .06 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6DC9Q167V3 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0065-1433-02 | Systane Balance | 1 in 1 CARTON | EMULSION | 1 | | 11 |
| 0065-1433-02 | Systane Balance | 10 mL in 1 BOTTLE, DROPPER | EMULSION | 10 | | 11 |
| 0065-1433-07 | Systane Balance | 2 in 1 CARTON | EMULSION | 2 | | 11 |
| 0065-1433-07 | Systane Balance | 10 mL in 1 BOTTLE, DROPPER | EMULSION | 10 | | 11 |
| 0065-1433-11 | Systane Balance | 1 in 1 CARTON | EMULSION | 1 | | 11 |
| 0065-1433-11 | Systane Balance | 1.5 mL in 1 BOTTLE, DROPPER | EMULSION | 1.5 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PROPYLENE GLYCOL | ACTIVE INGREDIENT | 6DC9Q167V3 | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| PROPYLENE GLYCOL | ACTIVE MOIETY | 6DC9Q167V3 | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- | INACTIVE INGREDIENT | BI71WT9P3R | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| GUAR GUM | INACTIVE INGREDIENT | E89I1637KE | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| POLYOXYL 40 STEARATE | INACTIVE INGREDIENT | 13A4J4NH9I | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| SORBITAN TRISTEARATE | INACTIVE INGREDIENT | 6LUM696811 | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-1433 | SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.] | 10 | Current NDC, Legacy NDC, 6 package rows | 20231216_c7b1a03a-a5f2-409e-a34a-d6f166671de5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0065-1433-02 | 00065143302 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-02) / 10 mL in 1 BOTTLE, DROPPER | 2010-06-25 | 0000-00-00 | No | No | Current |
| 0065-1433-07 | 00065143307 | 2 BOTTLE, DROPPER in 1 CARTON (0065-1433-07) / 10 mL in 1 BOTTLE, DROPPER | 2010-06-25 | 0000-00-00 | No | No | Current |
| 0065-1433-11 | 00065143311 | 1 BOTTLE, DROPPER in 1 CARTON (0065-1433-11) / 1.5 mL in 1 BOTTLE, DROPPER | 2010-06-25 | 0000-00-00 | No | No | Current |