Saline
- Product NDC
- 55319-047
- 11-digit product format
- 553190047
- Labeler code
- 55319
- Product ID
- 55319-047_d81cd494-6e67-4847-988e-24cdf89d0d6c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Saline
- Dosage form
- SPRAY
- Route
- NASAL
- Labeler
- FAMILY DOLLAR SERVICES INC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-07-28
- Substance
- SODIUM CHLORIDE
- Active strength
- 6.5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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
- Saline
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM CHLORIDE | 6.5 mg/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-047-15 | Saline | 1 in 1 CARTON | SPRAY | 1 | 8 | |
| 55319-047-15 | Saline | 44 mL in 1 BOTTLE | SPRAY | 44 | 8 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Iolite | BENZOCAINE | Dharma Research, Inc. | e4b2d22b-00b3-45a6-9b7d-8ee719587059 | 2023-10-09 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | a0e284f6-292f-4231-8596-f7cee4e0a12f | 2023-10-09 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fe92637a-c88a-f9dd-e053-6294a90a7fa3 | 2023-07-01 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | c979e958-2042-471a-bf03-e84e68620106 | 2023-06-20 | Warnings | M022 |
| Orajel Gum Pain 3X Medicated | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 9a1632ad-2b47-5653-e053-2995a90ae0d9 | 2023-01-20 | Warnings | M022 |
| KOLORZ TOPICAL ANESTHETIC TRIPLE MINT | BENZOCAINE | DMG AMERICA, LLC | 0f90b227-f938-4e1a-a79e-1967b1a0477e | 2021-10-01 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 707251 | sodium chloride 0.65 % Nasal Spray | PSN | 7d2acfff-e55b-48b9-9d36-4975563e08ff | 8 |
| 707251 | sodium chloride 6.5 MG/ML Nasal Spray | SCD | 7d2acfff-e55b-48b9-9d36-4975563e08ff | 8 |
| 707251 | NaCl 6.5 MG/ML Nasal Spray | SY | 7d2acfff-e55b-48b9-9d36-4975563e08ff | 8 |
| 707251 | sodium chloride 0.65 % Nasal Spray | SY | 7d2acfff-e55b-48b9-9d36-4975563e08ff | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55319-047-15 | 55319004715 | 1 BOTTLE in 1 CARTON (55319-047-15) / 44 mL in 1 BOTTLE | 1 bottle | 2020-07-28 | 0000-00-00 | No | No | Current |