Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl

Product NDC: 69729-322
11-digit product format: 697290322
Labeler code: 69729
Product ID: 69729-322_d9f8d76e-5f7a-fb3c-e053-2995a90a3125
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Dosage form: TABLET
Route: ORAL
Labeler: OPMX LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-08-26
Substance: ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 500; 4; 10 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 · 56 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69729-322-27	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69729-322-37	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69729-322-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69729-322-27	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69729-322-37	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69729-322-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69729-322-27	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69729-322-37	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69729-322-38	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69729-322-27	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69729-322-37	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69729-322-38	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69729-322-27	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69729-322-37	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69729-322-38	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69729-322-27	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69729-322-37	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69729-322-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69729-322-27	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69729-322-37	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69729-322-38	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69729-322-27	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69729-322-37	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69729-322-38	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69729-322-27	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69729-322-37	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69729-322-38	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69729-322-27	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69729-322-37	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69729-322-38	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69729-322-27	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69729-322-37	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69729-322-38	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69729-322-27	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69729-322-37	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69729-322-38	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69729-322-27	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69729-322-37	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69729-322-38	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69729-322-27	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69729-322-37	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69729-322-38	`bd6a592717d7…`	`303034d00443…`

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: Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	500 mg/1
CHLORPHENIRAMINE MALEATE	4 mg/1
PHENYLEPHRINE HYDROCHLORIDE	10 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
2463332	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
b3c229a4-c772-70fb-e053-2a95a90a72db	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
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
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, Related label table
NDC	Effective	Related label
69729-322-27	2025-03-18	Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-322-37	2025-03-18	Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-322-38	2025-03-18	Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-322-27	2022-01-28	Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-322-37	2022-01-28	Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)
69729-322-38	2022-01-28	Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69729-322-27	Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	2 in 1 POUCH	TABLET	2	2
69729-322-37	Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	12 in 1 POUCH	TABLET	12	2
69729-322-38	Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	144 in 1 POUCH	TABLET	144	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69729-322	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL TABLET [OPMX LLC]	2	Current NDC, Legacy NDC, 3 package rows	20250321_b3c229a4-c772-70fb-e053-2a95a90a72db.zip

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 155 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equaline nasal	OXYMETAZOLINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	07e0328e-1912-4f25-9e1e-9482d4665be0	2024-09-07	Warnings	Exact identifier application number: M012
Benadryl Allergy EXTRA STRENGTH	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	dd0a8069-18d8-5696-e053-2995a90a2f22	2024-09-06	Warnings	Exact identifier application number: M012
Guaifenesin and Codeine Phosphate	GUAIFENESIN AND CODEINE PHOSPHATE	PAI Holdings, LLC	88d0994c-4270-4408-8837-bd97510b2118	2024-09-06	Warnings	Exact identifier application number: M012
QCH Maximum Strength Mucus Relief 617	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Chain Drug Marketing Association Inc.	a1c5c15e-0f3a-47d3-b9ed-1e0018417514	2024-09-06	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Nighttime Soft Chews	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	6ba64bbe-7599-406a-9187-737c0f8c1c2a	2024-09-05	Warnings	Exact identifier application number: M012
Cough Relief Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	344282fc-3bd1-4f49-9bd1-08c5a58d1f73	2024-09-05	Warnings	Exact identifier application number: M012
Equate Nasal	PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	95ef1819-edc3-4dda-8514-85b61538cc72	2024-09-04	Warnings	Exact identifier application number: M012
Up and up nasal	OXYMETAZOLINE HYDROCHLORIDE	Target Corporation	0c246c11-eadd-4ac6-bd58-5fdb151e06d6	2024-09-04	Warnings	Exact identifier application number: M012
Exchange Select Nasal	OXYMETAZOLINE HYDROCHLORIDE	Army & Air Force Exchange Service	aafa9163-f08e-48c9-9ca1-7b72f67d007d	2024-08-31	Warnings	Exact identifier application number: M012
nasal 12 hour	OXYMETAZOLINE HYDROCHLORIDE	Meijer Distribution Inc	e9ee03db-a070-4c2b-ac61-7fd22bab2795	2024-08-31	Warnings	Exact identifier application number: M012
dg health nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	42b58928-e8e5-49e4-b49e-498d77d64fcd	2024-08-28	Warnings	Exact identifier application number: M012
nasal mist	OXYMETAZOLINE HCL	CVS Pharmacy	b71c557a-eb93-40d1-87c4-847f5468fc1e	2024-08-28	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HCL	Kroger Company	0a24d98a-5950-49de-8b77-ea880b08d2c5	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	96e018e2-e0b5-4802-a4a1-73a73d574082	2024-08-28	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HCL	Topco Associates LLC	b5434599-5485-4949-9d76-b1ef3ad17c1a	2024-08-28	Warnings	Exact identifier application number: M012
basic care no drip nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	b15eb271-7842-495b-aa0f-9b20def86dc1	2024-08-28	Warnings	Exact identifier application number: M012
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f1dd78e0-f700-4469-85d6-18cc299e8746	2024-08-28	Warnings	Exact identifier application number: M012
equaline nasal	OXYMETAZOLINE HCL	United Natural Foods, Inc. dba UNFI	69308693-a094-42a9-a041-e73647a25cc1	2024-08-27	Warnings	Exact identifier application number: M012
signature care nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f9ac80d1-3753-412b-a407-18a6b50e5d1c	2024-08-27	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	20ac6010-84f4-eeff-e063-6294a90a50a7	2024-08-27	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
2463332	acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	b3c229a4-c772-70fb-e053-2a95a90a72db	2
2463332	acetaminophen 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	b3c229a4-c772-70fb-e053-2a95a90a72db	2
2463332	APAP 500 MG / chlorpheniramine maleate 4 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SY	b3c229a4-c772-70fb-e053-2a95a90a72db	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69729-322-27	69729032227	2 TABLET in 1 POUCH (69729-322-27)	2 tablet	2019-08-26	0000-00-00	No	No	Current
69729-322-37	69729032237	12 TABLET in 1 POUCH (69729-322-37)	12 tablet	2019-08-26	0000-00-00	No	No	Current
69729-322-38	69729032238	144 TABLET in 1 POUCH (69729-322-38)	144 tablet	2019-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Resfriol D (Acetaminophen 500mg, Chlorpheniramine Maleate 4mg, Phenylephrine HCl 10mg Tablet)	OPMX LLC	2022-03-11	HUMAN OTC DRUG LABEL	2