Biolle Tears
- Product NDC
- 69994-001
- 11-digit product format
- 699940001
- Labeler code
- 69994
- Product ID
- 69994-001_96c60497-1326-4cf4-a63f-60b28164948d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Carboxymethylcellulose Sodium, Unspecified Form
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- SAGE Ethnographic Research, dba Bioll
- Application
- part349
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2015-06-01
- Marketing end
- 0000-00-00
- Substance
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- Active strength
- 5 mg/mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 69994-001 | I | Inactivated by FDA | 2026-10-16 | ||
| excluded package | package | 69994-001 | 69994-001-02 | I | Inactivated by FDA | 2026-10-16 | |
| excluded package | package | 69994-001 | 69994-001-04 | I | Inactivated by FDA | 2026-10-16 | |
| excluded package | package | 69994-001 | 69994-001-10 | I | Inactivated by FDA | 2026-10-16 | |
| excluded package | package | 69994-001 | 69994-001-32 | I | Inactivated by FDA | 2026-10-16 | |
| excluded package | package | 69994-001 | 69994-001-52 | I | Inactivated by FDA | 2026-10-16 | |
| excluded package | package | 69994-001 | 69994-001-72 | I | Inactivated by FDA | 2026-10-16 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69994-001-02 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69994-001-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69994-001-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69994-001-52 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69994-001-32 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69994-001-72 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69994-001-02 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69994-001-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69994-001-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69994-001-52 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69994-001-32 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69994-001-72 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69994-001-02 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69994-001-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69994-001-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69994-001-52 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69994-001-32 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69994-001-72 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69994-001-02 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69994-001-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69994-001-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69994-001-52 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69994-001-32 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69994-001-72 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69994-001-02 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69994-001-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69994-001-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69994-001-52 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69994-001-32 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69994-001-72 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69994-001-02 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69994-001-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69994-001-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69994-001-52 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69994-001-32 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69994-001-72 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69994-001-02 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69994-001-10 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69994-001-04 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69994-001-52 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69994-001-32 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69994-001-72 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69994-001-02 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69994-001-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69994-001-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69994-001-52 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69994-001-32 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69994-001-72 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69994-001-02 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69994-001-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69994-001-04 | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Related label |
|---|---|
| 69994-001-02 | Biollé Tears ® |
| 69994-001-04 | Biollé Tears ® |
| 69994-001-10 | Biollé Tears ® |
| 69994-001-32 | Biollé Tears ® |
| 69994-001-52 | Biollé Tears ® |
| 69994-001-72 | Biollé Tears ® |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69994-001-02 | Biolle Tears | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 1 | |
| 69994-001-02 | Biolle Tears | 4 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | 4 | 1 | |
| 69994-001-04 | Biolle Tears | 4 in 1 CARTON | SOLUTION/ DROPS | 4 | 1 | |
| 69994-001-04 | Biolle Tears | 4 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | 4 | 1 | |
| 69994-001-10 | Biolle Tears | 102 in 1 CARTON | SOLUTION/ DROPS | 102 | 1 | |
| 69994-001-10 | Biolle Tears | 4 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | 4 | 1 | |
| 69994-001-32 | Biolle Tears | 32 in 1 CARTON | SOLUTION/ DROPS | 32 | 1 | |
| 69994-001-32 | Biolle Tears | 4 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | 4 | 1 | |
| 69994-001-52 | Biolle Tears | 52 in 1 CARTON | SOLUTION/ DROPS | 52 | 1 | |
| 69994-001-52 | Biolle Tears | 4 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | 4 | 1 | |
| 69994-001-72 | Biolle Tears | 72 in 1 CARTON | SOLUTION/ DROPS | 72 | 1 | |
| 69994-001-72 | Biolle Tears | 4 mL in 1 VIAL, SINGLE-USE | SOLUTION/ DROPS | 4 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69994-001-32 | EA - Each | 69994-001 | 77b82ace-9c6f-4b2d-b9e4-34c0769501d9 | 1 | 2024-04-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69994-001 | BIOLLE TEARS (CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM) SOLUTION/ DROPS [SAGE ETHNOGRAPHIC RESEARCH, DBA BIOLLÉ] | 1 | Legacy NDC, 12 package rows | 20160328_f3d6856a-d447-4745-89e7-86cac83ce579.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1188426 | carboxymethylcellulose sodium 0.5 % Ophthalmic Solution | PSN | f3d6856a-d447-4745-89e7-86cac83ce579 | 1 |
| 1188426 | carboxymethylcellulose sodium 5 MG/ML Ophthalmic Solution | SCD | f3d6856a-d447-4745-89e7-86cac83ce579 | 1 |
| 1188426 | carboxymethylcellulose sodium 0.5 % Ophthalmic Solution | SY | f3d6856a-d447-4745-89e7-86cac83ce579 | 1 |
| 1188426 | carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic Solution | SY | f3d6856a-d447-4745-89e7-86cac83ce579 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 69994-001-02 | 69994000102 | 2 in 1 CARTON | Historical |
| 69994-001-04 | 69994000104 | 4 in 1 CARTON | Historical |
| 69994-001-10 | 69994000110 | 102 in 1 CARTON | Historical |
| 69994-001-32 | 69994000132 | 32 in 1 CARTON | Historical |
| 69994-001-52 | 69994000152 | 52 in 1 CARTON | Historical |
| 69994-001-72 | 69994000172 | 72 in 1 CARTON | Historical |