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 84 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SINUS PAIN AND CONGESTION	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS Pharmacy	697dffdd-5b56-4395-8e69-6b4360d9fdc5	2025-12-02	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	9c8c1974-f931-4493-abb5-ecdc32764ab3	2025-12-02	Warnings	Exact identifier application number: M012
Maximum Strength Mucus Relief Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores,Inc.,	770c0e4f-0eed-4b8c-85a5-761b6a84db62	2025-12-02	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	WAL-MART STORES INC	a2a7e568-bff8-4818-a31d-7c2efa1859c3	2025-12-02	Warnings	Exact identifier application number: M012
DayTime Severe, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLET	Lil' Drug Store Products, Inc.	44fa0193-2a19-bdc1-e063-6394a90a60e8	2025-12-02	Warnings	Exact identifier application number: M012
Nighttime Severe, Cold and Flu, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44fb9958-d771-f4b3-e063-6294a90a9135	2025-12-02	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief	GUAIFENESIN	Chain Drug Marketing Association	f1a73da7-0dbb-49bd-857e-7dd6bc11b63c	2025-12-02	Warnings	Exact identifier application number: M012
Cold and Flu Relief Daytime	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER 70000	ac74be47-30f0-418b-bd07-502feaa9723f	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens High Blood Pressure Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN	WALGREENS CO.	bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen High Blood Pressure Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Nighttime Kids Honey Cold Cough Congestion	DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO	c0f317cd-723d-47f2-b600-aaeae6399482	2025-12-01	Warnings	Exact identifier application number: M012
Walgreen Maximum Strength Severe Congestion and cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WALGREENS CO.	b4abcb6d-f3e1-4d63-98cf-ff556ec423b6	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Daytime Childrens	COUGH AND CHEST CONGESTION	WALGREENS CO.	dd99675f-3860-42ef-999c-d9a3746a38c0	2025-12-01	Warnings	Exact identifier application number: M012
Adult Cough plus Chest Congestion DM with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	WALGREEN COMPANY	5f5af13a-c2a3-4bbe-880e-9c57b36e9234	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	WALGREEN COMPANY	b2e08f4d-9753-4767-a8eb-3740dd1034cc	2025-12-01	Warnings	Exact identifier application number: M012
WALGREENS Cold Cough and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	1e903034-942e-4c6e-9f96-eb097c266580	2025-12-01	Warnings	Exact identifier application number: M012
Walgreens DAY and NIGHT PACK	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	WALGREEN CO	cb87e57b-ff06-4973-9751-137c7021e272	2025-12-01	Warnings	Exact identifier application number: M012
WALGREEN Multi Symptom Flu Relief Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	WALGREENS CO.	b7b1d604-921d-4ae7-93de-dcf690d421b4	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	235b2866-bbda-7148-e063-6394a90a898f	2025-12-01	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	32352109-31dc-8e6f-e063-6294a90a2f92	2025-12-01	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