Tussin

Product NDC: 70000-0133
11-digit product format: 700000133
Labeler code: 70000
Product ID: 70000-0133_a0437e58-7382-4a40-aa2a-9062850b63b4
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI
Dosage form: LIQUID
Route: ORAL
Labeler: Cardinal Health (Leader) 70000
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-01-31
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 20; 200; 10 mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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	70000-0133	70000-0133-2	D	Discontinued by firm		2026-10-23

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70000-0133-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70000-0133-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70000-0133-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70000-0133-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70000-0133-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70000-0133-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70000-0133-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70000-0133-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70000-0133-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70000-0133-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70000-0133-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70000-0133-2	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70000-0133-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70000-0133-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70000-0133-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70000-0133-2	`0efc9e666f02…`	`f202fb6c5f17…`

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
Brand name suffix: Multi Symptom Cold CF
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/10mL
GUAIFENESIN	200 mg/10mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	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
1044949	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
14c507df-fbac-4a09-a66c-b91c2abbf550	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
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
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70000-0133-1	TussinMulti Symptom Cold CF	1 in 1 BOX	LIQUID	1	9
70000-0133-1	TussinMulti Symptom Cold CF	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118	9
70000-0133-2	TussinMulti Symptom Cold CF	1 in 1 BOX	LIQUID	1	9
70000-0133-2	TussinMulti Symptom Cold CF	237 mL in 1 BOTTLE, PLASTIC	LIQUID	237	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70000-0133-1	ML - Milliliter	70000-0133	18a4519c-1a85-4a57-a100-9411f9073b93	1	2018-01-12
70000-0133-2	ML - Milliliter	70000-0133	558f3e9b-5f07-47b2-86df-b59a23468d57	1	2018-09-05

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 105 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ephedrine Sulfate	EPHEDRINE SULFATE	Walgreen Company	dc0072f9-7111-1af0-e053-2a95a90aed56	2025-09-04	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan HBr	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS Pharmacy, Inc	31aa77e0-cfdb-57a8-e063-6394a90af98c	2025-09-04	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	CVS Pharmacy, Inc.	4bb70a55-de44-3dc1-e054-00144ff8d46c	2025-09-04	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	CVS PHARMACY	a645b31e-7da7-4fe6-a04f-ac794ef52494	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de637b1-3402-db86-e063-6294a90ac981	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Medical Group Care LLC	f4a9cfec-0725-8f4a-e053-2995a90a1b4a	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de65c99-6c2d-3650-e063-6394a90aa98c	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C SUGAR-FREE	Medical Group Care LLC	f4a9d879-4736-4f63-e053-2995a90adeba	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de66240-441c-00ad-e063-6294a90a4a05	2025-09-03	Warnings	Exact identifier application number: M012
MGC Health	COUGH DROPS ASSORTED CITRUS VITAMIN C	Medical Group Care LLC	ff99c57a-e06a-69d3-e053-6394a90a6775	2025-09-03	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS VITAMIN C SUGAR-FREE	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	3de7ace0-e389-b751-e063-6394a90ab4e9	2025-09-03	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS VITAMIN C SUGAR-FREE	DISCOUNT DRUG MART	06673358-1afc-4d75-e063-6394a90a6ab1	2025-09-03	Warnings	Exact identifier application number: M012
ValuMeds Cough Relief, Dextromethorphan Hbr	DEXTROMETHORPHAN HYDROBROMIDE	Cabinet Health P.B.C.	b16a81db-d9bc-4cce-8ec2-dc189184931e	2025-09-03	Warnings	Exact identifier application number: M012
topcare day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	256d96f0-67bf-42d2-85ef-f49625c5910f	2025-09-02	Warnings	Exact identifier application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	2256623c-7642-4c39-b022-bfaecc861f1c	2025-09-02	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	ef574f18-e28d-46bb-87fd-2f3b4df6dc68	2025-09-02	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger Company	f4429475-47f9-451a-bfcc-24b5ef333923	2025-09-02	Warnings	Exact identifier application number: M012
dg health night time cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1	2025-08-29	Warnings	Exact identifier application number: M012
MGC Health Cough Drops Original Herb	MENTHOL	Medical Group Care LLC	3d70ba70-eb11-f148-e063-6294a90a4c7c	2025-08-28	Warnings	Exact identifier application number: M012
Exchange Select Cough Drops Original Herb	MENTHOL	Army & Air Force Exchange Service	3d7109a5-4fe1-039b-e063-6394a90a1392	2025-08-28	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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1044949	dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution	PSN	14c507df-fbac-4a09-a66c-b91c2abbf550	9
1044949	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD	14c507df-fbac-4a09-a66c-b91c2abbf550	9
1044949	dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution	SY	14c507df-fbac-4a09-a66c-b91c2abbf550	9
1044949	dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution	SY	14c507df-fbac-4a09-a66c-b91c2abbf550	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70000-0133-1	70000013301	1 BOTTLE, PLASTIC in 1 BOX (70000-0133-1) / 118 mL in 1 BOTTLE, PLASTIC	2017-01-31	0000-00-00	No	No	Current
70000-0133-2	70000013302	1 BOTTLE, PLASTIC in 1 BOX (70000-0133-2) > 237 mL in 1 BOTTLE, PLASTIC	2017-01-31	0000-00-00	No	No	Current