Defensol Adult Syrup

Product NDC: 53145-039
11-digit product format: 531450039
Labeler code: 53145
Product ID: 53145-039_3a89a0df-993d-f0d7-e063-6394a90a1c8b
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin, Dextromethorphan HBR
Dosage form: LIQUID
Route: ORAL
Labeler: Menper Distributors, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-02-21
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 200; 20 mg/10mL; mg/10mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	53145-039		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53145-039	53145-039-04	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

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: Defensol Adult Syrup
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	200 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996520	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
62acff69-8c40-4a0e-8d56-be2cc14e3d45	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-07-28	Defensol Adult Syrup
2022-02-18	Defensol Adult Syrup
2022-01-28	Defensol Adult Syrup
2020-02-04	Defensol Adult Syrup
2020-01-31	Defensol Adult Syrup

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53145-039-04	Defensol Adult Syrup	1 in 1 CARTON	LIQUID	1		6
53145-039-04	Defensol Adult Syrup	120 mL in 1 BOTTLE	LIQUID	120		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
CITRIC ACID ACETATE	INACTIVE INGREDIENT	DSO12WL7AU	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEFENSOL ADULT SYRUP (GUAIFENESIN, DEXTROMETHORPHAN HBR) LIQUID [MENPER DISTRIBUTORS, INC.]	2

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 110 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACTINEL PEDIATRIC	DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL	ACTIPHARMA, LLC	6bb92d74-4893-40b8-af58-eb307155e876	2025-07-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	776b7c67-56c7-420c-82b2-9a176d998396	2025-07-08	Warnings	Exact identifier application number: M012
ACTICON	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	847014ab-86ae-40c5-8e7f-f1ddea14f1b3	2025-07-08	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN 400 MG	Cabinet Health, Inc.	26a51b0e-039c-663c-e063-6394a90ad384	2025-07-07	Warnings	Exact identifier application number: M012
EZ Nite Sleep	DIPHENHYDRAMINE HCL	Safeway, Inc.	21a68c60-3005-43bb-8ec5-7982239c93f8	2025-07-07	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	8188b66a-5405-4e62-bde6-63ebc1f22b16	2025-07-04	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Meijer, Inc.	fdeadc2e-43e4-40d5-aebf-0e528f0a8b5a	2025-07-03	Warnings	Exact identifier application number: M012
Cabinet Allergy Relief Refill Diphenhydramine HCI	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	d47553a4-ca15-4f0a-8177-d743a5c39cc5	2025-07-03	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Advanced Rx LLC	20e164b8-4cbc-cf3f-e063-6394a90a9d0c	2025-07-02	Warnings	Exact identifier application number: M012
24/7 Life Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL OINTMENT	Lil' Drug Store Products, Inc.	f03430d4-8dbb-4fc0-e053-2a95a90a119d	2025-07-02	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	KJD Pharma Private Limited	b109249a-a0be-41bd-b6ce-ef621b588ddc	2025-07-02	Warnings	Exact identifier application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy	91c803c8-6cf8-4ff6-b376-ea6d65f9f227	2025-07-01	Warnings	Exact identifier application number: M012
WALGREENS Dye Free Chidrens Allergy Chews	DIPHENHYDRAMINE HCL	WALGREENS CO.	cc2fdc6b-8319-47c8-b036-37dbd65d5833	2025-06-30	Warnings	Exact identifier application number: M012
WALGREENS Dye Free Chidrens Allergy Chews	DIPHENHYDRAMINE HCL	WALGREENS CO.	91c369b0-8620-4764-a85d-a86402d9489c	2025-06-30	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGel	DIPHENHYDRAMINE HYDROCHLORIDE	Pioneer Life Sciences, LLC	bb9a82b1-ea7a-4d10-bc00-05013e83c4d3	2025-06-30	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	BETTER LIVING BRANDS, LLC	202f0661-461c-0333-e063-6294a90a96b5	2025-06-28	Warnings	Exact identifier application number: M012
Sugar Free Cough Drops	MENTHOL	CVS Pharmacy	f038b713-0721-2bb5-e053-2a95a90a7842	2025-06-26	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCl 25mg SoftGel	DIPHENHYDRAMINE HYDROCHLORIDE	NUVICARE LLC	bb728ceb-8eb0-4192-a8b0-742756819a05	2025-06-26	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	TIME CAP LABORATORIES, INC	7aee34b5-1583-4a8a-8ffb-b17ef2722ac1	2025-06-25	Warnings	Exact identifier application number: M012
ALLERGY RELIEF	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREENS	c0270298-e7c5-e500-e053-2995a90aed23	2025-06-25	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	62acff69-8c40-4a0e-8d56-be2cc14e3d45	6
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	62acff69-8c40-4a0e-8d56-be2cc14e3d45	6
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	62acff69-8c40-4a0e-8d56-be2cc14e3d45	6
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	62acff69-8c40-4a0e-8d56-be2cc14e3d45	6
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	62acff69-8c40-4a0e-8d56-be2cc14e3d45	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53145-039-04	53145003904	1 BOTTLE in 1 CARTON (53145-039-04) / 120 mL in 1 BOTTLE	1 bottle	2012-02-21	0000-00-00	No	No	Current