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 101 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens PediaClear 8	PYRILAMINE MALEATE	GM Pharmaceuticals, INC	8e524967-d01c-4c93-9198-c42f15fe3fe0	2025-10-03	Warnings	Exact identifier application number: M012
Childrens PediaClear PD	TRIPROLIDINE HYDROCHLORIDE	GM Pharmaceuticals, INC	f3ede5b7-1b0f-493a-b647-4459affc7e54	2025-10-03	Warnings	Exact identifier application number: M012
Guaifenesin and Dextromethorphan Hydrobromide	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	InvaTech Pharma Solutions LLC	40288ecf-043d-eb9e-e063-6394a90ac0a7	2025-10-02	Warnings	Exact identifier application number: M012
Guaifenesin 400	GUAIFENESIN TABLETS 400	InvaTech Pharma Solutions LLC	40291505-55ca-0759-e063-6394a90acee1	2025-10-02		Exact identifier application number: M012
CVS Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy	3dd5b783-5b64-24b5-e063-6394a90ab4ee	2025-10-02	Warnings	Exact identifier application number: M012
Acetaminophen and Diphenhydramine citrate	ACETAMINOPHEN AND DIPHENHYDRAMINE CITRATE	InvaTech Pharma Solutions LLC	403a88fa-e06b-9b6e-e063-6394a90a97b8	2025-10-02	Warnings	Exact identifier application number: M012
Equaline childrens cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	United Natural Foods, Inc. dba UNFI	3053f6d7-0eff-488c-8901-770dcc62af06	2025-10-02	Warnings	Exact identifier application number: M012
Rompe Pecho CF	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Dextrum Laboratories, Inc	401a97af-36ae-4e54-e063-6294a90ab3ee	2025-10-01	Warnings	Exact identifier application number: M012
NyQuil Severe plus Vicks VapoCool Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE	The Procter & Gamble Manufacturing Company	724d0889-5ba5-3125-e053-2a91aa0a92c1	2025-10-01	Warnings	Exact identifier application number: M012
DayQuil Severe plus Vicks VapoCool Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	724f2833-34bd-6a9e-e053-2991aa0a073d	2025-10-01	Warnings	Exact identifier application number: M012
Phenylephrine Hydrochloride	PHENYLEPHRINE HYDROCHLORIDE	InvaTech Pharma Solutions LLC	b8d360fa-0d80-f6a8-e053-2a95a90a8bd4	2025-10-01		Exact identifier application number: M012
LEADER TUSSIN CF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	f4ffe87b-0a62-44ac-b84a-08cf77cda7f5	2025-10-01	Warnings	Exact identifier application number: M012
Nasal Spray, 1oz, 24/7 Life by 7-Eleven	OXYMETAZOLINE HCL NASAL SOLUTION 0.05%	Lil' Drug Store Products, Inc.	3e781417-9ffc-f2c9-e063-6294a90a7205	2025-09-30	Warnings	Exact identifier application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough Suppressant	MENTHOL	Lofthouse of Fleetwood, Ltd.	d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf	2025-09-30	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dextrum Laboratories, Inc	3ff240ba-90b2-4c17-e063-6394a90ac56f	2025-09-29	Warnings	Exact identifier application number: M012
Dometuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dextrum Laboratories, Inc	3fcace53-a81f-e774-e063-6294a90a32fa	2025-09-27	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	f6a3680a-3ac6-4fd4-be52-ce29064c4aa1	2025-09-26	Warnings	Exact identifier application number: M012
No Drip Severe Nasal Mist	OXYMETAZOLINE SPRAY	CVS Health	9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae5	2025-09-26	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Dextrum Laboratories Inc.	3fa0b3be-2124-ed1d-e063-6294a90aaf48	2025-09-25	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Honey Herb	MENTHOL	Medical Group Care LLC	3fa17255-514f-db47-e063-6294a90ae454	2025-09-25	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