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 134 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Childrens Multi-symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Wal-Mart Stores, Inc.	177e3247-402d-98e4-e063-6294a90ae068	2024-11-26	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Flu, CVP	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE TABLET	Lil' Drug Store Products, Inc.	e7a27773-69d6-9e07-e053-2a95a90af8ea	2024-11-25	Warnings	Exact identifier application number: M012
DayTime Sinus Relief	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	4361912e-4b56-4743-b11d-acfb94482a2e	2024-11-25	Warnings	Exact identifier application number: M012
NightTime Sinus Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	413d82d3-a896-4f15-9fca-c1b7b9a1ee63	2024-11-25	Warnings	Exact identifier application number: M012
Night Cold Flu Cough and Allergy	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	590f4f0d-c8b0-412d-be1e-3eb2ccb29ac0	2024-11-25	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	cbd3a905-1c41-4cb0-8df6-36784430d627	2024-11-25	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	7a28d0fe-0e0a-453a-b604-1cc784dd153c	2024-11-25	Warnings	Exact identifier application number: M012
Cough and Cold plus	ACETAMINOPHEN, PHENYLEPHRINE HCL, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	c483d88f-cb0a-4dd6-b3ae-559521782ba6	2024-11-25	Warnings	Exact identifier application number: M012
DayTime Sinus	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	a0b01aef-4248-4d41-862c-0c8884dfca5e	2024-11-25	Warnings	Exact identifier application number: M012
DayTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	3af20739-6794-42e0-b404-3f0401d10a6d	2024-11-25	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg	DEXTROMETHORPHAN HBR	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.	ffc7e1e2-b664-461b-963d-764bad2f983f	2024-11-25	Warnings	Exact identifier application number: M012
NightTime Sinus	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	0f3b1404-9252-470a-aa8c-b360c85731f3	2024-11-25	Warnings	Exact identifier application number: M012
Maximum Strength-Cough and Chest Congestion DM	MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	d1830989-fe82-4f08-8618-78979fcef568	2024-11-25	Warnings	Exact identifier application number: M012
ASP Daytime PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	b84f2392-0b24-4af0-80f7-c45454093f51	2024-11-25	Warnings	Exact identifier application number: M012
ASP Nighttime Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	d8756d1f-baf5-412d-a493-a1c051eae302	2024-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	FOODHOLD U.S.A., LLC	508a65ee-42fa-4c0b-b24d-9faac6b0eba7	2024-11-24	Warnings	Exact identifier application number: M012
DG Day Time Cold and Flu Formula and Night Time Cold and Flu Formula	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	PuraCap Pharmaceutical LLC	cb68eef0-b027-4bf1-b78f-f31844a8c06c	2024-11-22	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	de2a64ce-c169-4162-b79e-d3809bea2147	2024-11-22	Warnings	Exact identifier application number: M012
12 Hour Nasal Decongestant Extra Moisturizing	NASAL SPRAY	WinCo Foods LLC	13fbde45-958c-455f-b766-f6a34342ee95	2024-11-21	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	a01abac3-c13e-40f2-ae98-34bd6c9b7504	2024-11-21	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