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.

Captured / source date, Dataset, Scope table
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	60665-003-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60665-003-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60665-003-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60665-003-01	`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	60665-003-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60665-003-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60665-003-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60665-003-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
acdc8740-6231-d1e8-e053-2995a90a3b8d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
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#

NDC, Effective, Related label table
NDC	Effective	Related label
60665-003-01	2026-01-13	acdc8740-6231-d1e8-e053-2995a90a3b8d
60665-003-02	2026-01-13	acdc8740-6231-d1e8-e053-2995a90a3b8d
60665-003-03	2026-01-13	acdc8740-6231-d1e8-e053-2995a90a3b8d
60665-003-04	2026-01-13	acdc8740-6231-d1e8-e053-2995a90a3b8d
60665-003-01	2025-07-29	acdc8740-6231-d1e8-e053-2995a90a3b8d
60665-003-02	2025-07-29	acdc8740-6231-d1e8-e053-2995a90a3b8d
60665-003-03	2025-07-29	acdc8740-6231-d1e8-e053-2995a90a3b8d
60665-003-04	2025-07-29	acdc8740-6231-d1e8-e053-2995a90a3b8d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60665-003-01	SambrosaNight	100 mL in 1 BOTTLE	SYRUP	100	8
60665-003-01	SambrosaNight	1 in 1 CARTON	SYRUP	1	8
60665-003-02	SambrosaNight	1 in 1 CARTON	SYRUP	1	8
60665-003-02	SambrosaNight	30 mL in 1 BOTTLE	SYRUP	30	8
60665-003-03	SambrosaNight	300 mL in 1 BOTTLE	SYRUP	300	8
60665-003-03	SambrosaNight	1 in 1 CARTON	SYRUP	1	8
60665-003-04	SambrosaNight	3 mL in 1 POUCH	SYRUP	3	8

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 152 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Black Cherry Cough Drops	MENTHOL	Boston Nutraceutical Production SL	856f2e1a-2593-99e6-e053-2991aa0ad039	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Boston Nutraceutical Production SL	857363b6-e025-e074-e053-2a91aa0a4379	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Boston Nutraceutical Production SL	857365ba-895e-4a63-e053-2991aa0a8b9f	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Vapor Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	a7062db1-8201-b400-e053-2a95a90a55e8	2024-10-07	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Boston Nutraceutical Production SL	b8f48a47-6871-f7ed-e053-2995a90a16f3	2024-10-07	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Boston Nutraceutical Production SL	856f0bd8-354b-a002-e053-2a91aa0a8022	2024-10-07	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Boston Nutraceutical Production SL	83c4928a-eea6-e176-e053-2991aa0a6bb1	2024-10-07	Warnings	Exact identifier application number: M012
Natural Herbal Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	c2340f56-9a8e-4eea-e053-2995a90a78fc	2024-10-07	Warnings	Exact identifier application number: M012
Natural Herbal Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	a706ee9c-9ed0-d3f1-e053-2a95a90a26d6	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff0b37b-6c08-b687-e053-2a95a90a11a9	2024-10-07	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	efcf2edd-21a3-45f9-e053-2995a90a3865	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff65505-8846-35c2-e053-2a95a90a6b79	2024-10-07	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	Topco Associates LLC	eff0fdfe-695a-4e62-e053-2a95a90ab50f	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff1a70f-fa71-52b2-e053-2995a90a038c	2024-10-07	Warnings	Exact identifier application number: M012
Honey Lemon Menthol Cough Drops	HONEY LEMON MENTHOL	Topco Associates LLC	f5be283b-524d-26af-e053-2995a90a3972	2024-10-07	Warnings	Exact identifier application number: M012
Cough Drops	MENTHOL	Topco Associates LLC	eff16ba3-7e30-aa93-e053-2995a90a64cb	2024-10-07	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Target Corporation Inc.	ebf6bcf5-9384-052a-e053-2a95a90a30a5	2024-10-07	Warnings	Exact identifier application number: M012
Rompe Pecho SF Flu SF Flu	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Efficient Laboratories Inc	06eac696-e8f6-ac50-e063-6394a90a2ed6	2024-10-07	Warnings	Exact identifier application number: M012
dg health nasal four	PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp, LLC	ceeeb016-8e46-40b8-9923-8a4270475f45	2024-10-04	Warnings	Exact identifier application number: M012
Topcare Nasal Four	PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	99bc8829-167b-4cf8-8421-57da369f24cd	2024-10-04	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2390292	doxylamine succinate 9.78 MG in 3 mL Oral Solution	PSN	acdc8740-6231-d1e8-e053-2995a90a3b8d	8
2390292	doxylamine succinate 3.26 MG/ML Oral Solution	SCD	acdc8740-6231-d1e8-e053-2995a90a3b8d	8
2390292	doxylamine succinate 9.78 MG per 3 mL Oral Solution	SY	acdc8740-6231-d1e8-e053-2995a90a3b8d	8

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sambrosa Night - Sambrosa Care, Inc. \| LGM Pharma Solutions, LLC	Sambrosa Care, Inc. \| LGM Pharma Solutions, LLC	2026-01-07	HUMAN OTC DRUG LABEL	8