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 59 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vapo Steam	VAPO STEAM	TOPCO ASSOCIATES, LLC	f216f69f-9580-25ac-e053-2995a90a5ac6	2026-01-14	Warnings	Exact identifier application number: M012
Leader Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Cardinal Health 110, LLC. dba Leader	f27bf0b2-25cc-474c-ab6b-f227ed3525fa	2026-01-14	Warnings	Exact identifier application number: M012
Sinus PE plus Allergy	CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	Walgreen Company	a15979d4-87bf-42e7-b1f2-783496072141	2026-01-13	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS LLC.	41f4bf6d-f83c-92e4-e063-6394a90aebab	2026-01-13	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	3e608643-1a74-b474-e063-6294a90ad2e0	2026-01-13	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	HYVEE INC	462cbf3d-51b1-dab9-e063-6394a90a70ba	2026-01-13	Warnings	Exact identifier application number: M012
Pocket Farmacy	MENTHOL	Saje Natural Business Inc.	4260542e-0980-4b0b-8177-1c9f2c53b5a6	2026-01-13	Warnings	Exact identifier application number: M012
Sweet Comfort	MENTHOL	Saje Natural Business Inc.	cf13cccd-723d-4d61-8a5e-b36281605cc7	2026-01-13	Warnings	Exact identifier application number: M012
Fortify	MENTHOL	Saje Natural Business Inc.	0320a305-99d1-4909-94cc-cd6509ecb948	2026-01-13	Warnings	Exact identifier application number: M012
Rolling Farmacy	MENTHOL	Saje Natural Business Inc.	a38765a9-22cd-4fc5-b5ab-c3cacbd52c74	2026-01-13	Warnings	Exact identifier application number: M012
Home Farmacy	MENTHOL	Saje Natural Business Inc.	add35d10-b27a-4ae8-b2de-8a285aaef155	2026-01-13	Warnings	Exact identifier application number: M012
Traveling Farmacy	MENTHOL	Saje Natural Business Inc.	5b70f5aa-ed36-65ab-e053-2a91aa0a6777	2026-01-13	Warnings	Exact identifier application number: M012
sinus plus allergy PE maximum strength	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	660d3c80-f249-41dd-aa93-a0b1e635ead0	2026-01-13	Warnings	Exact identifier application number: M012
Chest Comfort	MENTHOL	Saje Natural Business Inc.	8a3db169-6dd7-4dfd-8360-90315288f21b	2026-01-12	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	H E B	c9e977b6-fba6-49ea-9d80-b43b0842bbe1	2026-01-12	Warnings	Exact identifier application number: M012
PE Sinus Congestion	PHENYLEPHRINE HCL	Topco Associates, LLC	3264e291-7a0f-4e25-8390-ba441f22f650	2026-01-12	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	3f44cff6-240a-4a8d-aaa1-0da75a31a47b	2026-01-12	Warnings	Exact identifier application number: M012
Suphedrine PE Sinus Congestion Non-Drowsy	PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	b9122fd0-0bed-4302-9bbe-cd6a46d29818	2026-01-12	Warnings	Exact identifier application number: M012
Sinu-Phen Plus Sinus Pain and Pressure	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Wildman Business Group	c66e0b52-5531-4a84-ae90-8a26d27df1ec	2026-01-12	Warnings	Exact identifier application number: M012
SU PHEDRINE PE SINUS CONGESTION	PHENYLEPHRINE HCL	Salado Sales, Inc.	ba075ff7-4e26-4856-8335-0c7dd4e198ea	2026-01-12	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