Home NDC 60665-003 Sambrosa
Product NDC 60665-003
11-digit product format 606650003
Labeler code 60665
Product ID 60665-003_47ceb0bf-5593-9021-e063-6294a90a4ce1
Type HUMAN OTC DRUG
Nonproprietary name DOXYLAMINE SUCCINATE
Dosage form SYRUP
Route ORAL
Labeler Sambrosa Care, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-10
Substance DOXYLAMINE SUCCINATE
Active strength 9.78 mg/3mL
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Sambrosa
Brand name suffix Night
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOXYLAMINE SUCCINATE 9.78 mg/3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2390292 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60665-003 SAMBROSA NIGHT (DOXYLAMINE SUCCINATE) SYRUP [SAMBROSA CARE, INC.] 7 Current NDC, Legacy NDC, 7 package rows 20241027_acdc8740-6231-d1e8-e053-2995a90a3b8d.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.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60665-003-01 60665000301 1 BOTTLE in 1 CARTON (60665-003-01) / 100 mL in 1 BOTTLE 1 bottle 2020-01-10 0000-00-00 No No Current 60665-003-02 60665000302 1 BOTTLE in 1 CARTON (60665-003-02) / 30 mL in 1 BOTTLE 1 bottle 2020-12-01 0000-00-00 No No Current 60665-003-03 60665000303 1 BOTTLE in 1 CARTON (60665-003-03) / 300 mL in 1 BOTTLE 1 bottle 2020-01-10 0000-00-00 No No Current 60665-003-04 60665000304 3 mL in 1 POUCH (60665-003-04) 3 ml 2021-10-26 0000-00-00 No No Current