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 29 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	db264d2f-bf81-4da2-8595-2bfa1e4ba2f1	2026-05-18	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c	2026-05-15	Warnings	Exact identifier application number: M012
good neighbor pharmacy cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	da91e6b6-32ff-44fd-afce-33ea9549554b	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	847cdee8-410f-4ff3-9245-976ed6f4c776	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	d3b2f300-d919-44cd-ab71-b74b5bdfd977	2026-05-15	Warnings	Exact identifier application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER	ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS	MEDWISE LIFESCIENCES INC.	51d52ce4-98c4-2b9b-e063-6294a90ade44	2026-05-15	Warnings	Exact identifier application number: M012
Curewell Tussin DM	DEXTROMETHORPHAN, GUAIFENESIN	RMT HEALTH LLC	4fe9ad93-cdc4-b4df-e063-6294a90a90ae	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Orchard Cherry	MENTHOL	Melaleuca, Inc.	6049842c-d763-4a91-a225-976ed74e1693	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Honey Lemon	MENTHOL	Melaleuca, Inc.	84ac3489-9d64-401f-ab78-715af4de5440	2026-05-15	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	51e03b5b-b05a-07c1-e063-6394a90ab201	2026-05-15	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/Daytime	ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL	Rite Aid Corporation	38d73a1e-ac78-4f67-9291-bb48ab80306e	2026-05-15	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	WALMART INC.	071615ba-f50a-4d2a-a358-43140bccce72	2026-05-14	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	d4bcfabb-a054-4f53-8dc9-d361a03558b8	2026-05-14	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	4444c05a-eba6-4633-b86f-34f455699fa9	2026-05-14	Warnings	Exact identifier application number: M012
Topcare Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	a88e5b8e-e6dd-4a1c-9628-5861d3205bdb	2026-05-14	Warnings	Exact identifier application number: M012
equate daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	69b24c67-cf4b-46d7-a44b-d1917cc876b1	2026-05-14	Warnings	Exact identifier application number: M012
GILTUSS DIABETIC EX	GILTUSS DIABETIC EX	Gil Pharmaceutical Corp	ab7915e7-323a-4fe1-887a-a3bd3f0aac98	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Maximum Strength Expectorant	GILTUSS EX MAXIMUM STRENGTH EXPECTORANT	Gil Pharmaceutical Corp	950db1ca-6936-47f8-a112-e3594d4c922c	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GILTUSS EX EXPECTORANT	Gil Pharmaceutical Corp	3b363fb9-c4d3-446f-927c-f705ffc715b5	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss HBP EX Expectorant	GILTUSS HBP EX EXPECTORANT	Gil Pharmaceutical Corp	31bd6356-27cf-4188-8fd5-9cd9392021ca	2026-05-13	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