daytime

Product NDC: 56062-417
11-digit product format: 560620417
Labeler code: 56062
Product ID: 56062-417_88bcaae6-2494-4792-814f-089e38294aaa
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Publix Super Markets Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-08-30
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 5 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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 · 24 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
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	56062-417-73	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	56062-417-62	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	56062-417-73	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	56062-417-62	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	56062-417-73	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	56062-417-62	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	56062-417-73	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	56062-417-62	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	56062-417-73	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	56062-417-62	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	56062-417-73	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	56062-417-62	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	56062-417-73	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	56062-417-62	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	56062-417-73	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	56062-417-62	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: daytime
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 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
9D2RTI9KYH	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
1086997	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
c7cef266-46fc-49ab-a2e7-54fc56298659	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
56062-417-62	2025-11-05	Publix Super Markets, Inc. Daytime Drug Facts
56062-417-62	2025-11-05	Publix Super Markets, Inc. Daytime Drug Facts
56062-417-73	2025-11-05	Publix Super Markets, Inc. Daytime Drug Facts
56062-417-73	2025-11-05	Publix Super Markets, Inc. Daytime Drug Facts
56062-417-62	2025-01-30	Publix Super Markets, Inc. Daytime Drug Facts
56062-417-62	2025-01-30	Publix Super Markets, Inc. Daytime Drug Facts
56062-417-73	2025-01-30	Publix Super Markets, Inc. Daytime Drug Facts
56062-417-73	2025-01-30	Publix Super Markets, Inc. Daytime Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
56062-417-62	daytime	2 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	2	4
56062-417-62	daytime	12 in 1 CARTON	CAPSULE, LIQUID FILLED	12	4
56062-417-73	daytime	2 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	2	4
56062-417-73	daytime	8 in 1 CARTON	CAPSULE, LIQUID FILLED	8	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
56062-417	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [PUBLIX SUPER MARKETS INC]	3	Current NDC, Legacy NDC, 4 package rows	20221119_c7cef266-46fc-49ab-a2e7-54fc56298659.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 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
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	c7cef266-46fc-49ab-a2e7-54fc56298659	4
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	c7cef266-46fc-49ab-a2e7-54fc56298659	4
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	c7cef266-46fc-49ab-a2e7-54fc56298659	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
56062-417-62	56062041762	12 BLISTER PACK in 1 CARTON (56062-417-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	12 blister pack	2018-08-30	0000-00-00	No	No	Current
56062-417-73	56062041773	8 BLISTER PACK in 1 CARTON (56062-417-73) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	8 blister pack	2022-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Publix Super Markets, Inc. Daytime Drug Facts	Publix Super Markets Inc	2025-10-30	HUMAN OTC DRUG LABEL	4