Premier Value Tussin Cough

Product NDC: 68016-742
11-digit product format: 680160742
Labeler code: 68016
Product ID: 68016-742_97867b95-103e-4e6b-9746-e20aafef8d6a
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr
Dosage form: LIQUID
Route: ORAL
Labeler: Chain Drug Consortium, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-05-23
Substance: DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 30 mg/10mL
Pharmacologic classes: 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

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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68016-742-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68016-742-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68016-742-04	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68016-742-04	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68016-742-04	`1332a3947898…`	`d4bfe170f9cd…`

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: Premier Value Tussin Cough
Brand name suffix: Long Acting
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090496	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
0e393287-5bb8-458b-98c4-55fa16674d06	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-742-04	2024-10-28	C162847	48780-1	1030e365-5913-111a-e063-dadaa90a10e2	Premier Value Tussin Cough Log-Acting Drug Facts
68016-742-04	2024-01-30	C162847	48780-1	1030e365-5913-111a-e063-dadaa90a10e2	Premier Value Tussin Cough Log-Acting Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-742-04	Premier Value Tussin CoughLong Acting	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		6
68016-742-04	Premier Value Tussin CoughLong Acting	1 in 1 BOX	LIQUID	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-742	PREMIER VALUE TUSSIN COUGH LONG ACTING (DEXTROMETHORPHAN HBR) LIQUID [CHAIN DRUG CONSORTIUM, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241030_0e393287-5bb8-458b-98c4-55fa16674d06.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 147 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3dcf6cf-373c-ea83-e053-2a95a90ae57a	2024-10-17	Warnings	Exact identifier application number: M012
Sinus Pressure plus Pain PE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5918-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
SINUS AND HEADACHE	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e99dad-5916-6a90-e053-2a95a90a8803	2024-10-17	Warnings	Exact identifier application number: M012
ALLERGY MULTISYMPTOM	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a7e9ab8e-2252-180d-e053-2a95a90a788f	2024-10-17	Warnings	Exact identifier application number: M012
COLD PLUS HEAD CONGESTION SEVERE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	3430c7e4-e142-407e-bed5-358dd6bd10f7	2024-10-17	Warnings	Exact identifier application number: M012
COLD MAX	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	a1aba467-c91f-4812-b0b9-ff5fdfa298e3	2024-10-17	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e3dd12f1-dd63-27ae-e053-2995a90aaaeb	2024-10-17	Warnings	Exact identifier application number: M012
COLD and FLU SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	e44ac549-3e9b-4271-a2b2-ecb124f79832	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	f171a389-8b22-429c-86bc-272156fdc1b7	2024-10-17	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	6c5b5427-e47a-4eff-928a-c891452facf9	2024-10-17	Warnings	Exact identifier application number: M012
COLD AND FLU SEVERE	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	ddeb8978-84b6-4a19-b25e-99d1c29e58d9	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	b20baef9-6e68-6679-e053-2a95a90a2b63	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	b20b71fb-8787-c871-e053-2a95a90a8eb4	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	DISCOUNT DRUG MART	b20bc492-fed3-bf05-e053-2a95a90ad393	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	a4d6ecb9-ea67-41ed-917b-9bb4d1e50551	2024-10-17	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	08fda81a-bedd-4ff3-9c32-2066d2cea3f9	2024-10-17	Warnings	Exact identifier application number: M012
Guaifenesin	GUAIFENESIN	American Health Packaging	2fd702ea-3069-472c-b99e-c527f1375705	2024-10-17	Warnings	Exact identifier application number: M012
Mucus Relief Xpect	GUAIFENSIN, DEXTROMETHORPHAN	Selder, S.A. de C.V.	c2b49d10-b60f-3072-e053-2a95a90af004	2024-10-17	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	United Natural Foods, Inc. dba UNFI	1db914d3-8bba-405e-9bf9-9b1a5806284c	2024-10-17	Warnings	Exact identifier application number: M012
Cold Medicine XL3	ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE	Selder, S.A. de C.V.	e2c35fae-9dd6-51f2-e053-2995a90a1e9e	2024-10-17	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1090496	dextromethorphan HBr 15 MG in 5 mL Oral Solution	PSN	0e393287-5bb8-458b-98c4-55fa16674d06	6
1090496	dextromethorphan hydrobromide 3 MG/ML Oral Solution	SCD	0e393287-5bb8-458b-98c4-55fa16674d06	6
1090496	dextromethorphan hydrobromide 15 MG per 5 ML Oral Solution	SY	0e393287-5bb8-458b-98c4-55fa16674d06	6
1090496	dextromethorphan hydrobromide 30 MG per 10 ML Oral Solution	SY	0e393287-5bb8-458b-98c4-55fa16674d06	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-742-04	68016074204	1 BOTTLE, PLASTIC in 1 BOX (68016-742-04) / 118 mL in 1 BOTTLE, PLASTIC	2019-05-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premier Value Tussin Cough Log-Acting Drug Facts	Chain Drug Consortium, LLC	2024-10-28	HUMAN OTC DRUG LABEL	6