Daytime

Product NDC: 59779-656
11-digit product format: 597790656
Labeler code: 59779
Product ID: 59779-656_c930952c-1e5e-40a7-8cb5-c0a0089c1c2a
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan hbr, phenylephrine hcl
Dosage form: SOLUTION
Route: ORAL
Labeler: CVS Pharmacy
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-06-09
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59779-656	59779-656-30	D	Discontinued by firm		2026-10-15
excluded package	package	59779-656	59779-656-38	D	Discontinued by firm		2026-10-15

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, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	59779-656-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59779-656-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	59779-656-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59779-656-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	59779-656-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59779-656-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	59779-656-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59779-656-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	59779-656-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59779-656-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	59779-656-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59779-656-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	59779-656-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59779-656-38	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	59779-656-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59779-656-38	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	59779-656-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59779-656-38	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	59779-656-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59779-656-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	59779-656-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59779-656-38	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	59779-656-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59779-656-38	`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
Brand name suffix: Non Drowsy
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
d8339bb0-5da3-4f34-a819-339643cf4a97	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59779-656-30	DaytimeNon Drowsy	177 mL in 1 BOTTLE	SOLUTION	177	10
59779-656-34	DaytimeNon Drowsy	237 mL in 1 BOTTLE	SOLUTION	237	10
59779-656-38	DaytimeNon Drowsy	295 mL in 1 BOTTLE	SOLUTION	295	10
59779-656-40	DaytimeNon Drowsy	355 mL in 1 BOTTLE	SOLUTION	355	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-656-34	ML - Milliliter	59779-656	ea20003f-4905-4277-9db0-4f9420c86b71	1	2020-05-08

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 [CVS PHARMACY]	5
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	5
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	DAYTIME NIGHTTIME MULTI SYMPTOM COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-656	DAYTIME NON DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]	9	Current NDC, Legacy NDC, 4 package rows	20240927_d8339bb0-5da3-4f34-a819-339643cf4a97.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 80 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cherry throat relief lozenges	BENZOCAINE	Cintas Corporation	49b25e9e-1d47-4a10-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
cherry sore throat lozenge	BENZOCAINE	CVS Pharmacy	3c54974d-9d15-2fa1-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
honey lemon sore throat lozenges	BENZOCAINE	CVS Pharmacy	3c55009c-4b3e-135e-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
sugar free menthol cough drops	MENTHOL	CVS Pharmacy	3bdd24a8-3b44-00cd-e054-00144ff8d46c	2025-12-07	Warnings	Exact identifier application number: M012
sugar free honey lemon cough drops	MENTHOL	CVS Pharmacy	3c125b3a-e58f-5c06-e054-00144ff88e88	2025-12-07	Warnings	Exact identifier application number: M012
CVS Menthol Cough Drops	MENTHOL	CVS Pharmacy	de97d13b-bb67-d0e6-e053-2995a90aeb2c	2025-12-07	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	American Sales	34dd34d1-1a08-3470-e054-00144ff8d46c	2025-12-06	Warnings	Exact identifier application number: M012
DOLOGEN	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Kramer Novis	656ea9ba-c9cf-44c6-af40-b8ba292ce38a	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No Drip Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC	a79b5541-864b-412a-a085-96986ed6af59	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No Drip Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	346f32cb-74cb-4896-b770-76d5f829a17d	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No Drip Original Pump Mist	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	530b2d27-5883-489e-87fa-90b45eb93b3c	2025-12-05	Warnings	Exact identifier application number: M012
Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine	CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	ee666963-e686-4374-b52b-a677f1cd4114	2025-12-05	Warnings	Exact identifier application number: M012
Afrin No-Drip Allergy Sinus	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC	3beb5839-7422-449d-e054-00144ff88e88	2025-12-05	Warnings	Exact identifier application number: M012
Coricidin HBP Nighttime Multi-Symptom Cold	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	513ca24f-1262-4a2d-e054-00144ff8d46c	2025-12-05	Warnings	Exact identifier application number: M012
Afrin Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	Bayer HealthCare LLC.	a49a506e-aca2-4af0-a50b-dca2c031e61d	2025-12-05	Warnings	Exact identifier application number: M012
Throat Coat Sweet Orange Fennel	MENTHOL	Traditional Medicinals, Inc.	a746cef4-1fb4-45cf-e053-2995a90a02c8	2025-12-05	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	Health Pharma USA LLC	31755594-3e1c-b290-e063-6394a90aba61	2025-12-05	Warnings	Exact identifier application number: M012
Tabcin Extra Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,	Pharmadel LLC	0670c33e-8a3c-ae00-e063-6294a90a165b	2025-12-05	Warnings	Exact identifier application number: M012
Severe Sinus Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE	Shield Pharmaceuticals Corp	d0dd4a75-da65-4c66-b65f-54ee14100846	2025-12-05	Warnings	Exact identifier application number: M012
Basic Care Cherry Cough Drops	MENTHOL	Amazon.com	c0588221-0c84-66d8-e053-2995a90a874f	2025-12-05	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	d8339bb0-5da3-4f34-a819-339643cf4a97	10
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	d8339bb0-5da3-4f34-a819-339643cf4a97	10
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	d8339bb0-5da3-4f34-a819-339643cf4a97	10
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	d8339bb0-5da3-4f34-a819-339643cf4a97	10
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	d8339bb0-5da3-4f34-a819-339643cf4a97	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-656-30	59779065630	177 mL in 1 BOTTLE (59779-656-30)	177 ml	2006-08-09	0000-00-00	No	No	Current
59779-656-34	59779065634	237 mL in 1 BOTTLE (59779-656-34)	237 ml	2012-07-05	2026-11-30	No	No	Current
59779-656-38	59779065638	295 mL in 1 BOTTLE (59779-656-38)	295 ml	2006-06-09	0000-00-00	No	No	Current
59779-656-40	59779065640	355 mL in 1 BOTTLE (59779-656-40)	355 ml	2008-04-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Daytime Drug Facts	CVS Pharmacy	2026-05-08	HUMAN OTC DRUG LABEL	10
CVS Pharmacy, Inc. Daytime Nighttime Cold & Flu Relief Drug Facts	CVS Pharmacy	2024-11-14	HUMAN OTC DRUG LABEL	7