DayTime

Product NDC: 37808-656
11-digit product format: 378080656
Labeler code: 37808
Product ID: 37808-656_1064a193-f147-4611-9579-858580903f2d
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan Hbr, Phenylephrine HCl
Dosage form: SOLUTION
Route: ORAL
Labeler: H E B
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-08-02
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 5 mg/15mL; mg/15mL; mg/15mL
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: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	37808-656	37808-656-38	D	Discontinued by firm		2026-10-16

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/15mL

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
1113705	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
e2994c0f-add8-4f75-a6d2-24cd2af271e4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
37808-656-38	DayTime	296 mL in 1 BOTTLE	SOLUTION	296		10
37808-656-40	DayTime	355 mL in 1 BOTTLE	SOLUTION	355		10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
37808-656	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [H E B]	9	Current NDC, Legacy NDC, 2 package rows	20240927_e2994c0f-add8-4f75-a6d2-24cd2af271e4.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 125 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meclizine HCL	MECLIZINE HCL 25MG CHEWABLE TABLETS	Aphena Pharma Solutions - Tennessee, LLC	02d1af4d-d97d-4019-a5bf-3ec391238676	2025-01-09	Warnings	Exact identifier application number: M012
HISTEX PD Drops New Formulation	TRIPROLIDINE HYDROCHLORIDE	Allegis Pharmaceuticals, LLC	0c693f15-5d76-3dbf-e063-6294a90af9ac	2025-01-08	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HBR 15 MG	DEXTROMETHORPHAN HBR 15 MG	AMZ789 LLC	e2175017-6a0d-0155-e053-2995a90a65d6	2025-01-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	Health Pharma USA LLC	29bb7822-76c6-e39d-e063-6294a90a64fb	2025-01-07	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	CHILDRENS ALLERGY RELIEF	Allegiant Health	cb6df361-b8e5-4e2f-945f-c20159d76c4f	2025-01-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	WinCo Foods, LLC	bb7a9fed-dc04-4c31-aa7f-4185d955242c	2025-01-06	Warnings	Exact identifier application number: M012
Leader Childrens Cold and Cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Cardinal Health 110, LLC. dba Leader	207b2677-aaad-4fe4-a96d-963b7dcfba70	2025-01-06	Warnings	Exact identifier application number: M012
Allergy Relief Caplet	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	126c05e7-2cd9-47d3-96c3-82305714e1db	2025-01-02	Warnings	Exact identifier application number: M012
Right Remedies Adult Long Lasting Cough Relief Softgel	DEXTROMETHORPHAN HYDROBROMIDE	Strive Pharmaceuticals Inc.	e3ea468e-4e12-4dae-b222-8e32456b77b8	2025-01-02	Warnings	Exact identifier application number: M012
AVON HeXashield Congestion Relief Original	OXYMETAZOLINE HYDROCHLORIDE	Tai Guk Pharm. Co., Ltd.	8f2c152c-c564-0cba-e053-2a95a90ab3c7	2025-01-01	Warnings	Exact identifier application number: M012
Multi-Symptom Nighttime Cold and Flu Relief	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR	Advanced Rx LLC	a75553bd-f3f0-47bd-b3c3-aeeb0d1a81b4	2025-01-01	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE	Advanced Rx LLC	297e10e3-e740-4434-91a2-2e5c54985d33	2025-01-01	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	GUAIFENESIN, DEXTROMETHORPHAN HBR	Advanced Rx LLC	64620186-a45b-4c35-a3b9-a347348f93f7	2025-01-01	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Best Choice	57a44bbf-a304-47b9-8adc-4442c7787853	2025-01-01	Warnings	Exact identifier application number: M012
Long Acting Cough Softgels	DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY, INC	322daee6-c61d-43d3-a54d-a354fd3df242	2025-01-01	Warnings	Exact identifier application number: M012
Adult Tussin DM Lil Drug Store Products	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Lil' Drug Store Products, Inc	1915cf2a-ebaa-4c47-8991-5b741fa01be2	2024-12-31	Warnings	Exact identifier application number: M012
Congestion Relief Lil Drug Store Products	OXYMETAZOLINE HYDROCHLORIDE	Lil' Drug Store Products, Inc	8fca348c-ecb6-4a91-89dd-8bd4c05ac745	2024-12-31	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU MULTI SYMPTOM	DAYTIME COLD AND FLU MULTI SYMPTOM	TARGET CORP	9dea350d-2f09-b944-e053-2995a90a2b63	2024-12-30	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreens	2b7aa3f5-3bc9-471f-8ff7-3c52719f0acb	2024-12-30	Warnings	Exact identifier application number: M012
Pediacare Childrens Cough and Cold Grape	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	fabafdc1-9dd8-4258-af49-bab1e29ad109	2024-12-30	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
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	e2994c0f-add8-4f75-a6d2-24cd2af271e4	10
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	e2994c0f-add8-4f75-a6d2-24cd2af271e4	10
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	e2994c0f-add8-4f75-a6d2-24cd2af271e4	10
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	e2994c0f-add8-4f75-a6d2-24cd2af271e4	10
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	e2994c0f-add8-4f75-a6d2-24cd2af271e4	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
37808-656-38	37808065638	296 mL in 1 BOTTLE (37808-656-38)	296 ml	2006-08-02	0000-00-00	No	No	Current
37808-656-40	37808065640	355 mL in 1 BOTTLE (37808-656-40)	355 ml	2012-07-20	0000-00-00	No	No	Current