Defensol D

Product NDC: 53145-005
11-digit product format: 531450005
Labeler code: 53145
Product ID: 53145-005_3a88bd55-586f-64c5-e063-6394a90a6788
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Chlorpherinamine maleate, Phenylephrine HCI
Dosage form: TABLET
Route: ORAL
Labeler: Menper Distributors, Inc.
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-02-21
Substance: ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 2; 5 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 21 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
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53145-005-30	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53145-005-02	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53145-005-30	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53145-005-02	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53145-005-30	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53145-005-02	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53145-005-30	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53145-005-02	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
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	53145-005-30	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53145-005-02	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	53145-005-30	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53145-005-02	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	53145-005-02	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	53145-005-30	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 D
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
CHLORPHENIRAMINE MALEATE	2 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
V1Q0O9OJ9Z	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
1046781	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
f466c660-69eb-4581-81ff-1499fa421d8b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-005-02	2020-01-31	C162847	48780-1	9d75b9d0-3370-f424-e053-dadaa90a57ce	Defensol D
53145-005-30	2020-01-31	C162847	48780-1	9d75b9d0-3370-f424-e053-dadaa90a57ce	Defensol D

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53145-005-02	Defensol D	50 in 1 CARTON	TABLET	50	5
53145-005-02	Defensol D	2 in 1 PACKAGE	TABLET	2	5
53145-005-30	Defensol D	30 in 1 BOTTLE	TABLET	30	5
53145-005-30	Defensol D	1 in 1 BOX	TABLET	1	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DEFENSOL D (ACETAMINOPHEN, CHLORPHERINAMINE MALEATE, PHENYLEPHRINE HCI) TABLET [MENPER DISTRIBUTORS, INC.]	1

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 88 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aprodine	PSEUDOEPHEDRINE HCL, TRIPROLIDINE HCL	Major Pharmaceuticals	6612e514-2690-4f5b-8a82-0e54d362758f	2025-11-19	Warnings	Exact identifier application number: M012
Cough Drops Gems Flawless Cherry Flavor 30ct	MENTHOL	Riclan S.A.	0f0260df-89ac-4b83-afea-3aff56ff1b43	2025-11-18	Warnings	Exact identifier application number: M012
Cough Drops Gems Flawless Honey Lemon Flavor 30ct	MENTHOL	Riclan S.A.	16f6d531-9298-4172-8d08-ecd87d6add76	2025-11-18	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	a6f750c8-8738-4965-a3ad-612c24611056	2025-11-18	Warnings	Exact identifier application number: M012
YINCHIAO	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	09ba45f6-03e1-46b9-83ab-a618b2626716	2025-11-18	Warnings	Exact identifier application number: M012
GANMAOLING	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	c757a03e-59ea-469c-970d-4bc62e73f36f	2025-11-18	Warnings	Exact identifier application number: M012
M-Dryl	DIPHENHYDRAMINE HYDROCHLORIDE	Bryant Ranch Prepack	e1d545dc-9222-4d61-964d-1c781215d7d2	2025-11-18	Warnings	Exact identifier application number: M012
Goodnow cold flu day relief cold flu night relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Gobrands, Inc	7590d0c6-121e-4016-b6bb-534c5d0a7970	2025-11-17	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	R J General Corporation	d786ae07-ce57-44c7-9ba5-f4c87df115de	2025-11-17	Warnings	Exact identifier application number: M012
Benadryl Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	R J General Corporation	c46c01c0-29f4-400c-bef5-14b3eb944c51	2025-11-17	Warnings	Exact identifier application number: M012
TYLENOL COLD AND FLU	ACETAMINPHEN	R J General Corporation	b618877b-9dbc-4ba2-be2c-bf1922c646cc	2025-11-17	Warnings	Exact identifier application number: M012
TYLENOL SINUS SEVERE	ACETAMINOPHEN	R J General Corporation	2cbf7954-b28f-4d7b-b142-6c6c5c58b25d	2025-11-17	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	R J General Corporation	8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc	2025-11-17	Warnings	Exact identifier application number: M012
Quality Choice Medicated Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	QUALITY CHOICE (Chain Drug Marketing Association)	c0e3c959-bed6-2ce5-e053-2995a90a0be9	2025-11-17	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	c5ea5a7a-c806-e5e0-e053-2995a90a15e9	2025-11-17	Warnings	Exact identifier application number: M012
Multi-Symptom Flu HBP	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	50f3157b-5788-4b63-835a-e60c8dc33df9	2025-11-17	Warnings	Exact identifier application number: M012
Day and Night Sinus	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Wal-Mart Stores Inc	a9d809f5-63a1-4f80-8b4d-33e8e052c7bd	2025-11-15	Warnings	Exact identifier application number: M012
Cold and Flu Day, Night	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	937b481a-e0b7-4d34-a8a1-0bfb2b867c2b	2025-11-15	Warnings	Exact identifier application number: M012
Sinus Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	f701a6ae-200d-48dc-94e4-6bd3228f50d4	2025-11-15	Warnings	Exact identifier application number: M012
MULTI-SYMPTOM COLD	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	b1fae7cc-4033-44bc-aa7c-ca3ceea51c7d	2025-11-15	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046781	acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	f466c660-69eb-4581-81ff-1499fa421d8b	5
1046781	acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	f466c660-69eb-4581-81ff-1499fa421d8b	5
1046781	APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SY	f466c660-69eb-4581-81ff-1499fa421d8b	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53145-005-02	53145000502	50 PACKAGE in 1 CARTON (53145-005-02) / 2 TABLET in 1 PACKAGE	50 package	2012-02-21	No	No	Current
53145-005-30	53145000530	1 BOTTLE in 1 BOX (53145-005-30) / 30 TABLET in 1 BOTTLE	1 bottle	2012-02-21	No	No	Current