SprinJene Natural
- Product NDC
- 63404-1984
- 11-digit product format
- 634041984
- Labeler code
- 63404
- Product ID
- 63404-1984_4e23f203-d473-4e73-ab56-d9270e4c49e9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Potassium Nitrate
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Health and Natural Beauty USA Corp
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-02-20
- Substance
- POTASSIUM NITRATE
- Active strength
- 50 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|
| 2025-04-01 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 | 63404-1984-1 | 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 | 63404-1984-1 | 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 | 63404-1984-1 | 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 | 63404-1984-1 | 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 | 63404-1984-1 | 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 | 63404-1984-1 | 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 | 63404-1984-1 | 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 | 63404-1984-1 | 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 | 63404-1984-1 | 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 | 63404-1984-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 63404-1984-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 63404-1984-1 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 63404-1984-1 | 1332a3947898… | d4bfe170f9cd… |
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
- SprinJene Natural
- Brand name suffix
- Sensitivity and Gum
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POTASSIUM NITRATE | 50 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| RU45X2JN0Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 312544 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3cb23e36-0e8c-4172-b4ae-859b58a2739f | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63404-1984-1 | 2025-07-08 | C162847 | 48780-1 | f386c64a-3a0d-0266-e053-dadaa90a7c1a | SprinJene Natural ® Sensitivity & Gum |
| 63404-1984-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3a0d-0266-e053-dadaa90a7c1a | SprinJene Natural ® Sensitivity & Gum |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63404-1984-1 | SprinJene Natural Sensitivity and Gum | 142 g in 1 TUBE | PASTE, DENTIFRICE | 142 | 2 | |
| 63404-1984-1 | SprinJene Natural Sensitivity and Gum | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63404-1984 | SPRINJENE NATURAL SENSITIVITY AND GUM (POTASSIUM NITRATE) PASTE, DENTIFRICE [HEALTH AND NATURAL BEAUTY USA CORP] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210220_3cb23e36-0e8c-4172-b4ae-859b58a2739f.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 |
|---|---|---|---|---|---|---|
| Red Cross Canker Sore | BENZOCAINE | The Mentholatum Company | 54cfff96-6665-4b36-a15d-10bf6cf3a1f9 | 2024-12-17 | Warnings | M022 |
| Benzoin Tincture | BENZOIN RESIN | 116956644 | 2981217f-f250-c090-e063-6294a90a85b0 | 2024-12-17 | Warnings | M022 |
| Kank-A Mouth Pain | BENZOCAINE | Blistex Inc. | eebc03ba-f849-4e70-a653-834f383b6aa4 | 2024-12-17 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8282a4a6-b77c-75fc-e053-2991aa0ad4ac | 2024-12-16 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | 9452bff4-8c08-eff9-e053-2a95a90a67ed | 2024-12-16 | Warnings | M022 |
| PHENOL | PHENOL | CHAIN DRUG MARKETING ASSOCIATION INC. | 2379e23a-72fe-4e94-9d7e-9b623c0db174 | 2024-12-13 | Warnings | M022 |
| KANKA SoftBrush | BENZOCAINE AND ZINC CHLORIDE | Blistex Inc | 093f3545-1d8e-48a3-a533-e9c3ae6d740b | 2024-12-12 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 826eaef8-4457-3dc2-e053-2991aa0a528b | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 8281700c-10f9-841c-e053-2991aa0a918f | 2024-12-11 | Warnings | M022 |
| Topicale | BENZOCAINE | Medical Products Laboratories, Inc. | 82824416-80de-76bd-e053-2a91aa0ad8b5 | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories,Inc. | e3da0e63-a891-72bd-e053-2a95a90a58bc | 2024-12-11 | Warnings | M022 |
| Topicale Xtra | BENZOCAINE | Medical Products Laboratories, Inc. | e3d924b5-0788-46d3-e053-2995a90a027b | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | fa433031-7376-0e5b-e053-6394a90a5f75 | 2024-12-11 | Warnings | M022 |
| Fluoride Bits | SODIUM MONOFLUOROPHOSPHATE 0.76% | The Kind Lab, Inc. | eedf13dc-a009-027a-e053-2995a90a8ec8 | 2024-12-11 | Warnings | M022 |
| NATURAL LEMON MINT HERB THROAT DROPS | MENTHOL | Ricola USA Inc. | 763e8234-60be-4b1f-9f78-01c574f35d0a | 2024-12-10 | Warnings | M022 |
| Natural Cherry Honey Herb Throat Drops | MENTHOL | Ricola USA Inc. | 989f8509-cd28-48e7-9aa1-baddfbcac95a | 2024-12-10 | Warnings | M022 |
| ORGANIC PEPPERMINT HERB THROAT DROPS | MENTHOL | Ricola USA Inc. | f75c8967-40e6-473a-b403-941354cb0be1 | 2024-12-10 | Warnings | M022 |
| Natural Cherry Honey Herb Throat Drops | MENTHOL | Ricola USA Inc. | c56be34d-1dd5-4200-9723-3a73180cb759 | 2024-12-10 | Warnings | M022 |
| Cherry Throat Drops | MENTHOL | Ricola USA Inc. | 89257ceb-af0f-4516-88f7-6dfdab9e14f4 | 2024-12-10 | Warnings | M022 |
| BERRY MEDLEY THROAT DROPS | MENTHOL | Ricola USA Inc. | 9bfd2ea7-745b-47f8-bd8a-9dbeeaad8b95 | 2024-12-10 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 312544 | potassium nitrate 5 % Toothpaste | PSN | 3cb23e36-0e8c-4172-b4ae-859b58a2739f | 2 |
| 312544 | potassium nitrate 0.05 MG/MG Toothpaste | SCD | 3cb23e36-0e8c-4172-b4ae-859b58a2739f | 2 |
| 312544 | K+ nitrate 0.05 MG/MG Toothpaste | SY | 3cb23e36-0e8c-4172-b4ae-859b58a2739f | 2 |
| 312544 | Pot nitrate 0.05 MG/MG Toothpaste | SY | 3cb23e36-0e8c-4172-b4ae-859b58a2739f | 2 |
| 312544 | potassium nitrate 5 % Toothpaste | SY | 3cb23e36-0e8c-4172-b4ae-859b58a2739f | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 63404-1984-1 | 63404198401 | 1 TUBE in 1 CARTON (63404-1984-1) / 142 g in 1 TUBE | 1 tube | 2021-02-20 | 0000-00-00 | No | No | Current |