Tussin

Product NDC: 53943-507
11-digit product format: 539430507
Labeler code: 53943
Product ID: 53943-507_295839b6-abfd-43ed-be25-fcb9724d9afd
Type: HUMAN OTC DRUG
Nonproprietary name: GUAIFENESIN
Dosage form: LIQUID
Route: ORAL
Labeler: Discount Drug Mart
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-11-19
Substance: GUAIFENESIN
Active strength: 100 mg/5mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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 · 4 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
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53943-507-26	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53943-507-26	`9bebd1f3094a…`	`5416666fcb17…`

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: Tussin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUAIFENESIN	100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310604	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
14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
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
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53943-507-26	2020-12-31	C162847	48780-1	9d75b9d0-f93a-f424-e053-dadaa90a57ce	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71
53943-507-26	2020-01-31	C162847	48780-1	9d75b9d0-f93a-f424-e053-dadaa90a57ce	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-507-26	Tussin	237 mL in 1 BOTTLE	LIQUID	237		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
DEXTROSE	INACTIVE INGREDIENT	IY9XDZ35W2	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-507	TUSSIN (GUAIFENESIN) LIQUID [DISCOUNT DRUG MART]	5	Current NDC, Legacy NDC, 1 package rows	20241222_14de3d6d-4eb0-42cf-8941-cb42b3dd5c71.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 30 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Fast-Max Severe Congestion and Cough	GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	1991d5ee-fc90-4070-8965-cd6f4abc45cf	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Severe Congestion and Cough and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3b2bb6d0-c5fa-3bfa-e063-6294a90a7afc	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	3ba2cc08-acad-79a8-e063-6394a90af17f	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	a3523aa3-9ed1-472d-9986-438440d0a3eb	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Fast-Max DM Max and Mucinex Nightshift Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	2ed3c844-0532-40d9-beba-738d196de34d	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion and Pain	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	1e243dbe-138f-4346-ba22-ceea01e97052	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Nightshift Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	a14bc0d1-9b05-4a21-aaa8-95d4d073b9ed	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion Relief	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	128f3442-9802-4303-80be-aead09237936	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	33f0d9bb-c67d-92ba-e063-6294a90a9943	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Severe Congestion and Pain, Maximum Strength	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	2c01962d-74e3-4dfa-b7cb-a91a687711d5	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	f5365c6d-9296-41a5-953a-d1008954e67f	2026-05-13	Warnings	Exact identifier application number: M012
Mucinex Sinus-Max Pressure, Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	8905706b-b9da-4520-8cf2-87d7c125edf3	2026-05-13	Warnings	Exact identifier application number: M012
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 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310604	guaiFENesin 100 MG in 5 mL Oral Solution	PSN	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	6
310604	guaifenesin 20 MG/ML Oral Solution	SCD	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	6
310604	guaifenesin 100 MG per 5 ML Oral Solution	SY	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	6
310604	guaifenesin 100 MG per 5 ML Oral Syrup	SY	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	6
310604	guaifenesin 200 MG per 10 ML Oral Solution	SY	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	6
310604	guaifenesin 300 MG per 15 ML Oral Solution	SY	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	6
310604	guaifenesin 400 MG per 20 ML Oral Solution	SY	14de3d6d-4eb0-42cf-8941-cb42b3dd5c71	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-507-26	53943050726	237 mL in 1 BOTTLE (53943-507-26)	237 ml	2014-11-19	0000-00-00	No	No	Current