Sambrosa
- Product NDC
- 80148-001
- 11-digit product format
- 801480001
- Labeler code
- 80148
- Product ID
- 80148-001_d7c6e95f-6ec9-4316-e053-2a95a90ac39c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DOXYLAMINE SUCCINATE
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Lelypharma bv
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2020-01-10
- Marketing end
- 0000-00-00
- Substance
- DOXYLAMINE SUCCINATE
- Active strength
- 10 mg/3mL
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 80148-001 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 80148-001 | 80148-001-01 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 80148-001 | 80148-001-02 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 80148-001 | 80148-001-03 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 80148-001 | 80148-001-04 | I | Inactivated by FDA | 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 | 80148-001-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80148-001-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80148-001-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 80148-001-02 | 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 | 80148-001-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80148-001-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80148-001-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 80148-001-02 | f5e01cc5f278… | a2eaf40c39c3… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 59361619-24d9-b610-eca6-5a7f25ed5e03 | Product name | 5 | 20240909 |
| f4368033-af8c-41bf-a84b-ff77392b8522 | Product name | 1 | 20161229 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80148-001-01 | Sambrosanight | 100 mL in 1 BOTTLE | SYRUP | 100 | 7 | |
| 80148-001-01 | Sambrosanight | 1 in 1 CARTON | SYRUP | 1 | 7 | |
| 80148-001-02 | Sambrosanight | 1 in 1 CARTON | SYRUP | 1 | 7 | |
| 80148-001-02 | Sambrosanight | 30 mL in 1 BOTTLE | SYRUP | 30 | 7 | |
| 80148-001-03 | Sambrosanight | 300 mL in 1 BOTTLE | SYRUP | 300 | 7 | |
| 80148-001-03 | Sambrosanight | 1 in 1 CARTON | SYRUP | 1 | 7 | |
| 80148-001-04 | Sambrosanight | 3 mL in 1 POUCH | SYRUP | 3 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2390292 | doxylamine succinate 9.78 MG in 3 mL Oral Solution | PSN | adca020a-29e7-ecdd-e053-2a95a90a0b94 | 7 |
| 2390292 | doxylamine succinate 3.26 MG/ML Oral Solution | SCD | adca020a-29e7-ecdd-e053-2a95a90a0b94 | 7 |
| 2390292 | doxylamine succinate 9.78 MG per 3 mL Oral Solution | SY | adca020a-29e7-ecdd-e053-2a95a90a0b94 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 80148-001-01 | 80148000101 | 1 BOTTLE in 1 CARTON (80148-001-01) > 100 mL in 1 BOTTLE | 1 bottle | 2020-01-10 | 0000-00-00 | No | No | Current |
| 80148-001-02 | 80148000102 | 1 BOTTLE in 1 CARTON (80148-001-02) > 30 mL in 1 BOTTLE | 1 bottle | 2020-12-01 | 0000-00-00 | No | No | Current |
| 80148-001-03 | 80148000103 | 1 BOTTLE in 1 CARTON (80148-001-03) > 300 mL in 1 BOTTLE | 1 bottle | 2020-01-10 | 0000-00-00 | No | No | Current |
| 80148-001-04 | 80148000104 | 3 mL in 1 POUCH (80148-001-04) | 3 ml | 2021-10-26 | 0000-00-00 | No | No | Current |