NightTime

Product NDC: 30142-459
11-digit product format: 301420459
Labeler code: 30142
Product ID: 30142-459_19f6e983-9579-4ca6-afc5-28b0a86c69b5
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: Kroger Company
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-08-26
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
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: 2026-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	30142-459		D	Discontinued by firm	2026-08-17
excluded package	package	30142-459	30142-459-30	D	Discontinued by firm	2026-08-17
excluded package	package	30142-459	30142-459-34	D	Discontinued by firm	2026-08-17
excluded package	package	30142-459	30142-459-38	D	Discontinued by firm	2026-08-17
excluded package	package	30142-459	30142-459-40	D	Discontinued by firm	2026-08-17

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 · 36 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	30142-459-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	30142-459-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	30142-459-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	30142-459-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	30142-459-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	30142-459-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	30142-459-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	30142-459-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	30142-459-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	30142-459-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	30142-459-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	30142-459-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	30142-459-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	30142-459-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	30142-459-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	30142-459-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	30142-459-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	30142-459-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	30142-459-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	30142-459-38	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	30142-459-34	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	30142-459-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	30142-459-38	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	30142-459-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	30142-459-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	30142-459-38	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	30142-459-34	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	30142-459-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	30142-459-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	30142-459-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	30142-459-34	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	30142-459-38	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	30142-459-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	30142-459-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	30142-459-38	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	30142-459-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
30142-459-30	NightTime	177 mL in 1 BOTTLE	SOLUTION	177	10
30142-459-34	NightTime	237 mL in 1 BOTTLE	SOLUTION	237	10
30142-459-38	NightTime	295 mL in 1 BOTTLE	SOLUTION	295	10
30142-459-40	NightTime	354 mL in 1 BOTTLE	SOLUTION	354	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	NITE TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	5
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	NITE TIME DAY TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [KROGER COMPANY]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
30142-459	NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [KROGER COMPANY]	10	Current NDC, Legacy NDC, 4 package rows	20241027_5aa3ba10-6561-4685-9ad7-1badd318ddc0.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 1 of 195 · 3,893 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	610accad-2f8b-4605-9357-a58e6e18d417	2026-08-15	Warnings	Exact identifier application number: M012
CVS Childrens COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	CVS PHARMACY	27820bce-6638-4f17-ac66-62b02b76bec3	2026-08-14	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE	CVS PHARMACY, INC.	004e104b-d6ff-48d5-8685-cd1bff45399a	2026-08-14	Warnings	Exact identifier application number: M012
CHILDRENS DIMETAPP COLD AND COUGH	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	7babf4f6-ca0a-44a7-b1ea-d60e20d36f15	2026-08-14	Warnings	Exact identifier application number: M012
CVS Mucus Relief DM and Overnight Cold and Flu	DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL	CVS	75520b77-d40b-4f43-b92a-7a3eba5b493f	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY	bb24c298-1d00-4378-8de3-b4056220fa75	2026-08-14	Warnings	Exact identifier application number: M012
SEVERE COLD PLUS FLU DAYTIME NIGHTTIME	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS Pharmacy,Inc.	6cb1d08b-e544-4084-b9ed-1e0d99a709c8	2026-08-14	Warnings, Adverse reactions	Exact identifier application number: M012
Theraflu Relief Max Strength Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	932a3d40-9b52-4e91-bc61-6fd506f2d9e6	2026-08-14	Warnings	Exact identifier application number: M012
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	CVS Pharmacy,Inc.	91063edd-1e7e-41e9-8412-b14ef3749018	2026-08-14	Warnings	Exact identifier application number: M012
CVS Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS PHARMACY, INC.	f4020c08-29f6-4609-834e-191ce6885130	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Cough, Flu Plus Sore Throat Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	95203001-7ca6-4513-83a3-9ef17855bc0f	2026-08-14	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	81d26e9c-b713-4fb3-b0a5-68526bad230e	2026-08-14	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	e9d0b6f9-e9f3-431c-9f34-4d63108282a1	2026-08-13	Warnings	Exact identifier application number: M012
daytime nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Amazon.com Services LLC	9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e	2026-08-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	1e3c81b0-05de-4c4a-8579-f301f14626b3	2026-08-13	Warnings	Exact identifier application number: M012
Tussin DM Daytime Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d59f6c64-8311-48ba-90d1-8000b04bfcda	2026-08-13	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5578e6-7e67-c467-e063-6294a90a6e0b	2026-08-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f95220c5-e55c-4271-a267-d004ad2447bf	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	569b8efa-8458-49f7-a665-6b7016a10505	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY DYE FREE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7	2026-08-12	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
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	5aa3ba10-6561-4685-9ad7-1badd318ddc0	10
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	5aa3ba10-6561-4685-9ad7-1badd318ddc0	10
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	5aa3ba10-6561-4685-9ad7-1badd318ddc0	10
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	5aa3ba10-6561-4685-9ad7-1badd318ddc0	10
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	5aa3ba10-6561-4685-9ad7-1badd318ddc0	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
30142-459-30	30142045930	177 mL in 1 BOTTLE	177 ml					Historical
30142-459-34	30142045934	237 mL in 1 BOTTLE	237 ml					Historical
30142-459-38	30142045938	295 mL in 1 BOTTLE	295 ml					Historical
30142-459-40	30142045940	354 mL in 1 BOTTLE (30142-459-40)	354 ml	2013-08-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kroger Co. Nite Time Drug Facts	Kroger Company	2024-10-25	HUMAN OTC DRUG LABEL	10
Kroger Co. NightTime DayTime Drug Facts	Kroger Company	2023-05-08	HUMAN OTC DRUG LABEL	9