Defensol-ito

Product NDC: 53145-333
11-digit product format: 531450333
Labeler code: 53145
Product ID: 53145-333_3a8ae61d-30c1-903c-e063-6394a90ae5c2
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan, Guiafenesin, Phenylephrine
Dosage form: SOLUTION
Route: ORAL
Labeler: Menper Distributors, Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 4; 50; 2.5 mg/mL; mg/mL; mg/mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53145-333-15	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53145-333-15	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53145-333-15	E	Excluded after deficient or non-compliant submission was not corrected	`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-ito
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	4 mg/mL
GUAIFENESIN	50 mg/mL
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1661314	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
a7c7a60d-d49f-4239-92f7-714eac7eb0c5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-333-15	2023-07-28	C162847	48780-1	9d75b9d0-fdb7-f424-e053-dadaa90a57ce	Defensol-ito solution
53145-333-15	2021-08-09	C162847	48780-1	9d75b9d0-fdb7-f424-e053-dadaa90a57ce	Defensol-ito solution
53145-333-15	2020-01-31	C162847	48780-1	9d75b9d0-fdb7-f424-e053-dadaa90a57ce	Defensol-ito solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53145-333-15	Defensol-ito	30 mL in 1 BOTTLE, DROPPER	SOLUTION	30		8
53145-333-15	Defensol-ito	1 in 1 CARTON	SOLUTION	1		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
CORN SYRUP	INACTIVE INGREDIENT	9G5L16BK6N	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	DEFENSOL-ITO (DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE) SOLUTION [MENPER DISTRIBUTORS, INC]	5

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 105 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	6ccbd537-2264-4b3c-804e-3d3ea5368a5f	2025-09-05	Warnings	Exact identifier application number: M012
Ephedrine Sulfate	EPHEDRINE SULFATE	Walgreen Company	dc0072f9-7111-1af0-e053-2a95a90aed56	2025-09-04	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc	31aa77e0-cfdb-57a8-e063-6394a90af98c	2025-09-04	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	CVS Pharmacy, Inc.	4bb70a55-de44-3dc1-e054-00144ff8d46c	2025-09-04	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	CVS PHARMACY	a645b31e-7da7-4fe6-a04f-ac794ef52494	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de637b1-3402-db86-e063-6294a90ac981	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Medical Group Care LLC	f4a9cfec-0725-8f4a-e053-2995a90a1b4a	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de65c99-6c2d-3650-e063-6394a90aa98c	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE	Medical Group Care LLC	f4a9d879-4736-4f63-e053-2995a90adeba	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de66240-441c-00ad-e063-6294a90a4a05	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Medical Group Care LLC	ff99c57a-e06a-69d3-e053-6394a90a6775	2025-09-03	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS VITAMIN C SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de7ace0-e389-b751-e063-6394a90ab4e9	2025-09-03	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS VITAMIN C SUGAR-FREE	DISCOUNT DRUG MART	06673358-1afc-4d75-e063-6394a90a6ab1	2025-09-03	Warnings	Exact identifier application number: M012
ValuMeds Cough Relief, Dextromethorphan Hbr	DEXTROMETHORPHAN HYDROBROMIDE	Cabinet Health P.B.C.	b16a81db-d9bc-4cce-8ec2-dc189184931e	2025-09-03	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	256d96f0-67bf-42d2-85ef-f49625c5910f	2025-09-02	Warnings	Exact identifier application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	2256623c-7642-4c39-b022-bfaecc861f1c	2025-09-02	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	ef574f18-e28d-46bb-87fd-2f3b4df6dc68	2025-09-02	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger Company	f4429475-47f9-451a-bfcc-24b5ef333923	2025-09-02	Warnings	Exact identifier application number: M012
dg health night time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1	2025-08-29	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Original Herb	MENTHOL	Medical Group Care LLC	3d70ba70-eb11-f148-e063-6294a90a4c7c	2025-08-28	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1661314	dextromethorphan HBr 4 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution	PSN	a7c7a60d-d49f-4239-92f7-714eac7eb0c5	8
1661314	dextromethorphan hydrobromide 4 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution	SCD	a7c7a60d-d49f-4239-92f7-714eac7eb0c5	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53145-333-15	53145033315	1 BOTTLE, DROPPER in 1 CARTON (53145-333-15) / 30 mL in 1 BOTTLE, DROPPER	2014-01-01	0000-00-00	No	No	Current