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 21 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	bfec14d5-d9ce-4b9c-a803-3d01cb00b56c	2026-06-22	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	WinCo Foods, LLC	5f1aaa8e-c65f-43b3-9850-c60c1663d78f	2026-06-22	Warnings	Exact identifier application number: M012
DAY TIME INTENSE FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Meijer, Inc.	e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a	2026-06-22	Warnings	Exact identifier application number: M012
NO DRIP NASAL	PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	7a866cdf-1c0c-403a-afc8-0e99e0ce81aa	2026-06-22	Warnings	Exact identifier application number: M012
Maximum Strength Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	KROGER COMPANY	30d4c4b9-0f5f-0279-e063-6394a90af1b5	2026-06-19	Warnings	Exact identifier application number: M012
GoodMeds Nasal Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	6a8a961c-d2d2-428d-8af7-8527aae25c8a	2026-06-19	Warnings	Exact identifier application number: M012
equaline nighttime cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	United Natural Foods, Inc. dba UNFI	490766e7-1781-4b2b-a8f4-d4efb9fff560	2026-06-19	Warnings	Exact identifier application number: M012
Equate Nasal	PHENYLEPHRINE HYDROCHLORIDE	WALMART INC.	30f6d588-ad80-4348-a45f-77337e067bca	2026-06-19	Warnings	Exact identifier application number: M012
GUAIFENESIN	GUAIFENESIN	Cardinal Health 107, LLC	888b6a2e-6631-4585-a7fe-eb122eb51b23	2026-06-18	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Cold plus Flu Multi Symptom Day	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	5487b2e1-b0e5-0236-e063-6394a90a3a8b	2026-06-18	Warnings	Exact identifier application number: M012
Vaporizing Colds Rub	MENTHOL	Delon Laboratories (1990) Ltd	3ed8bc0c-c229-450b-a491-06b578c1b8ee	2026-06-18	Warnings	Exact identifier application number: M012
Allergy Childrens	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	218c447e-9ddd-428a-9b33-0acec35e0d1b	2026-06-17	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	WALMART INC.	a9d5f9f4-ddec-4ad6-ad06-4a612008bb68	2026-06-17	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	e49d2a0f-6588-439b-8a46-c073e0bc4f9a	2026-06-17	Warnings	Exact identifier application number: M012
COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway	ac0380ad-c9fa-4bda-ab84-c2e6aa672bdf	2026-06-17	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1a21cbb2-1ba5-414f-a31f-42b7a7bddae5	2026-06-16	Warnings	Exact identifier application number: M012
Tussin DM Regular	DEXTROMETHORPHAN HBR AND GUAIFENESIN	AARNA USA, Inc.	5460c809-71c8-3ad6-e063-6294a90a4e4f	2026-06-16	Warnings	Exact identifier application number: M012
Equate Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	4b111580-cd20-43ec-9ff4-4b9f74f7d2e8	2026-06-16	Warnings	Exact identifier application number: M012
Sinus Congestion	PHENYLEPHRINE HCL	Chain Drug Marketing Association, Inc.	43a77f89-e66a-4db6-8067-f614c0e207df	2026-06-16	Warnings	Exact identifier application number: M012
severe sinus congestion relief Maximum Strength	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	51175d3e-e1c3-4e4d-ad32-61600e87568c	2026-06-16	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