FDA.reportPublic FDA data

Sambrosa

Product NDC
80148-001
Requested package NDC
80148-001-01
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.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80148-00180148-001-01IInactivated by FDA2026-10-05

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.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage80148-00180148-001-01IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage80148-00180148-001-01IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
80148-001-01adca020a-29e7-ecdd-e053-2a95a90a0b94
80148-001-02adca020a-29e7-ecdd-e053-2a95a90a0b94
80148-001-03adca020a-29e7-ecdd-e053-2a95a90a0b94
80148-001-04adca020a-29e7-ecdd-e053-2a95a90a0b94

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80148-001-01Sambrosanight100 mL in 1 BOTTLESYRUP1007
80148-001-01Sambrosanight1 in 1 CARTONSYRUP17
80148-001-02Sambrosanight1 in 1 CARTONSYRUP17
80148-001-02Sambrosanight30 mL in 1 BOTTLESYRUP307
80148-001-03Sambrosanight300 mL in 1 BOTTLESYRUP3007
80148-001-03Sambrosanight1 in 1 CARTONSYRUP17
80148-001-04Sambrosanight3 mL in 1 POUCHSYRUP37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80148-001SAMBROSA NIGHT (DOXYLAMINE SUCCINATE) SYRUP [LELYPHARMA BV]7Legacy NDC, 7 package rows20241027_adca020a-29e7-ecdd-e053-2a95a90a0b94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2390292doxylamine succinate 9.78 MG in 3 mL Oral SolutionPSNadca020a-29e7-ecdd-e053-2a95a90a0b947
2390292doxylamine succinate 3.26 MG/ML Oral SolutionSCDadca020a-29e7-ecdd-e053-2a95a90a0b947
2390292doxylamine succinate 9.78 MG per 3 mL Oral SolutionSYadca020a-29e7-ecdd-e053-2a95a90a0b947

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80148-001-01801480001011 BOTTLE in 1 CARTON (80148-001-01) > 100 mL in 1 BOTTLE1 bottle2020-01-100000-00-00NoNoCurrent