Oxygen
- Product NDC
- 61398-0828
- 11-digit product format
- 613980828
- Labeler code
- 61398
- Product ID
- 61398-0828_458b7740-d228-721b-e063-6394a90a15f2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Oxygen
- Dosage form
- GAS
- Route
- RESPIRATORY (INHALATION)
- Labeler
- Complete Care Inc
- Marketing category
- UNAPPROVED MEDICAL GAS
- Marketing start
- 2009-12-02
- Substance
- OXYGEN
- Active strength
- 99 L/100L
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | 61398-0828 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 61398-0828 | 61398-0828-1 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 61398-0828 | 61398-0828-2 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 61398-0828 | 61398-0828-3 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 61398-0828 | 61398-0828-4 | D | Discontinued by firm | 2026-10-05 |
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 | 61398-0828-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61398-0828-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61398-0828-3 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61398-0828-2 | 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 | 61398-0828-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61398-0828-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61398-0828-3 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61398-0828-2 | 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 | 61398-0828-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61398-0828-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61398-0828-3 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61398-0828-2 | 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 | 61398-0828-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61398-0828-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61398-0828-3 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61398-0828-2 | 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 | 61398-0828-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61398-0828-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61398-0828-3 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61398-0828-2 | 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 | 61398-0828-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61398-0828-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61398-0828-3 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61398-0828-2 | 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 | 61398-0828-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61398-0828-4 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61398-0828-3 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61398-0828-2 | 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 | 61398-0828-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61398-0828-4 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61398-0828-3 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61398-0828-2 | 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 | 61398-0828-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61398-0828-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61398-0828-3 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61398-0828-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61398-0828-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61398-0828-4 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61398-0828-3 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61398-0828-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61398-0828-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61398-0828-4 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61398-0828-3 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61398-0828-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61398-0828-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61398-0828-4 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61398-0828-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61398-0828-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Oxygen
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OXYGEN | 99 L/100L |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| S88TT14065 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312172 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 950da03f-dfc3-bdb5-e053-2995a90ab33d | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Related label |
|---|---|
| 61398-0828-1 | Oxygen, USP |
| 61398-0828-2 | Oxygen, USP |
| 61398-0828-3 | Oxygen, USP |
| 61398-0828-4 | Oxygen, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61398-0828-0 | Oxygen | 3455 L in 1 CYLINDER | GAS | 3455 | 8 | |
| 61398-0828-5 | Oxygen | 170 L in 1 CYLINDER | GAS | 170 | 8 | |
| 61398-0828-6 | Oxygen | 255 L in 1 CYLINDER | GAS | 255 | 8 | |
| 61398-0828-7 | Oxygen | 425 L in 1 CYLINDER | GAS | 425 | 8 | |
| 61398-0828-8 | Oxygen | 680 L in 1 CYLINDER | GAS | 680 | 8 | |
| 61398-0828-9 | Oxygen | 1738 L in 1 CYLINDER | GAS | 1738 | 8 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Oxygen | ACTIVE INGREDIENT | S88TT14065 | OXYGEN GAS [COMPLETE CARE INC] | 1 | |
| Oxygen | ACTIVE MOIETY | S88TT14065 | OXYGEN GAS [COMPLETE CARE INC] | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61398-0828 | OXYGEN GAS [COMPLETE CARE INC ] | 9 | Current NDC, Legacy NDC | 20181128_5eb002b0-4412-400b-aa77-47880319198b.zip |
| 61398-0828 | OXYGEN GAS [COMPLETE CARE INC] | 7 | Current NDC, Legacy NDC, 6 package rows | 20241123_950da03f-dfc3-bdb5-e053-2995a90ab33d.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 |
|---|---|---|---|---|---|---|
| Oxygen | OXYGEN | Complete Care Inc | 950da03f-dfc3-bdb5-e053-2995a90ab33d | 2025-12-09 | 61398-0828 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312172 | oxygen 99 % Gas for Inhalation | PSN | 950da03f-dfc3-bdb5-e053-2995a90ab33d | 8 |
| 312172 | oxygen 99 % Gas for Inhalation | SCD | 950da03f-dfc3-bdb5-e053-2995a90ab33d | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61398-0828-0 | 61398082800 | 3455 L in 1 CYLINDER (61398-0828-0) | 3455 l | 2009-12-02 | 0000-00-00 | No | No | Current |
| 61398-0828-5 | 61398082805 | 170 L in 1 CYLINDER (61398-0828-5) | 170 l | 2009-12-02 | 0000-00-00 | No | No | Current |
| 61398-0828-6 | 61398082806 | 255 L in 1 CYLINDER (61398-0828-6) | 255 l | 2009-12-02 | 0000-00-00 | No | No | Current |
| 61398-0828-7 | 61398082807 | 425 L in 1 CYLINDER (61398-0828-7) | 425 l | 2009-12-02 | 0000-00-00 | No | No | Current |
| 61398-0828-8 | 61398082808 | 680 L in 1 CYLINDER (61398-0828-8) | 680 l | 2009-12-02 | 0000-00-00 | No | No | Current |
| 61398-0828-9 | 61398082809 | 1738 L in 1 CYLINDER (61398-0828-9) | 1738 l | 2009-12-02 | 0000-00-00 | No | No | Current |