nitetime

Product NDC: 56062-056
11-digit product format: 560620056
Labeler code: 56062
Product ID: 56062-056_9d583684-8de7-4128-9186-6d102e0b8607
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Publix Super Markets Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-02-17
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: nitetime
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/1
DOXYLAMINE SUCCINATE	6.25 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
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094549	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
f681d986-9838-42d8-8ed9-732a39fbf870	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
56062-056-62	nitetime	2 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	2	6
56062-056-62	nitetime	12 in 1 CARTON	CAPSULE, LIQUID FILLED	12	6
56062-056-73	nitetime	8 in 1 CARTON	CAPSULE, LIQUID FILLED	8	6
56062-056-73	nitetime	2 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	2	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, GELATIN COATED [PUBLIX SUPER MARKETS INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
56062-056	NITETIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [PUBLIX SUPER MARKETS INC]	5	Current NDC, Legacy NDC, 4 package rows	20241017_f681d986-9838-42d8-8ed9-732a39fbf870.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 31 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCINEX Rapid Clear Day Night and Clear and Cool Nasal	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	37dcb0ed-df56-1bec-e063-6394a90a695e	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool	OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN	Reckitt Benckiser LLC	373e0d75-8def-4b98-e063-6394a90a5e47	2026-05-13	Warnings	Exact identifier application number: M012
MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL	OXYMETAZOLINE HYDROCHLORIDE	Reckitt Benckiser LLC	5a397466-8721-4060-a178-5ebfd7069cc9	2026-05-13	Warnings	Exact identifier application number: M012
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	350764de-7801-b24e-e063-6394a90ab3c3	2026-05-13	Warnings	Exact identifier application number: M012
Cepacol Extra Strength Sore Throat and Cough	BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	c0cc32db-90f0-4106-8538-89821083ece1	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Cold and Flu	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	e8bc4131-f7b0-926a-e053-2995a90a40ac	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Cold, Flu, and Sore Throat	ACETAMINOPHEN, GUAIFENESIN	Reckitt Benckiser LLC	37ded76a-ee8d-f22c-e063-6394a90a00c2	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Night Time Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	fdb5c937-c148-eb46-e053-6394a90a8bed	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Cough Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Reckitt Benckiser LLC	e9c32d81-cd9b-4ff2-e053-2995a90aa499	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	316b5569-b66f-f30c-e063-6394a90ae147	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	d9467ca2-df75-4fa1-92b3-d2101eb54a77	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Severe Cold and Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	12420092-3ef6-464b-9106-2d56cd6ef200	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Sinus Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	09fdf96f-345f-43f2-9f0f-8303ac70849e	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Childrens Mighty Chews Night Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE	Reckitt Benckiser LLC	2ce31244-9c6c-b7dd-e063-6394a90a31a8	2026-05-13	Warnings	Exact identifier application number: M012
equate daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	2ac53cc7-000f-41fd-b799-4e6d6886fe62	2026-05-13	Warnings	Exact identifier application number: M012
nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Publix Super Markets Inc	2201d5c0-bd51-47a7-9775-916b18573623	2026-05-13	Warnings	Exact identifier application number: M012
topcare nite time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Topco Associates LLC	f868e4a0-e9fb-4e6a-9984-29a218246241	2026-05-13	Warnings	Exact identifier application number: M012
nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Meijer Distribution Inc	582fa36b-6d0c-4ff3-80ab-6e0da4b209e4	2026-05-13	Warnings	Exact identifier application number: M012
SudoGest	PSEUDOEPHEDRINE HYDROCHLORIDE	Major Pharmaceuticals	78faa497-6743-b85b-e053-2a91aa0ae822	2026-05-12	Warnings	Exact identifier application number: M012
Allergy Relief mini Softgels	DIPHENHYDRAMINE HCI 25 MG	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	df1c620b-ff59-4126-99a5-1d6750888f2b	2026-05-12	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
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	f681d986-9838-42d8-8ed9-732a39fbf870	6
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	f681d986-9838-42d8-8ed9-732a39fbf870	6
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	f681d986-9838-42d8-8ed9-732a39fbf870	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
56062-056-62	56062005662	12 BLISTER PACK in 1 CARTON (56062-056-62) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	12 blister pack	2014-02-24	0000-00-00	No	No	Current
56062-056-73	56062005673	8 BLISTER PACK in 1 CARTON (56062-056-73) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	8 blister pack	2014-02-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Publix Super Markets, Inc. Nitetime Drug Facts	Publix Super Markets Inc	2026-01-19	HUMAN OTC DRUG LABEL	6