Tussin DMMax

Product NDC: 69618-072
11-digit product format: 696180072
Labeler code: 69618
Product ID: 69618-072_47fd1379-0cd5-9b54-e063-6394a90a3948
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: RELIABLE 1 LABORATORIES LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-12-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20; 400 mg/20mL; mg/20mL
Pharmacologic classes: 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]
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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69618-072-58	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69618-072-58	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69618-072-58	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69618-072-58	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69618-072-58	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69618-072-58	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69618-072-58	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69618-072-58	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69618-072-58	U	Excluded because listing certification expired	`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 DMMax
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/20mL
GUAIFENESIN	400 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
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
1020138	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
c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2026-01-09	c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa
2026-01-09	Reliable Tussin DMMax 072
2025-01-30	c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa
2025-01-30	Reliable Tussin DMMax 072

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69618-072-58	Tussin DMMax	237 mL in 1 BOTTLE	LIQUID	237		4
69618-072-58	Tussin DMMax	1 in 1 CARTON	LIQUID	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69618-072-58	ML - Milliliter	69618-072	d0861b1b-d68a-4692-8b58-656623c98299	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69618-072	TUSSIN DMMAX (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [RELIABLE 1 LABORATORIES LLC]	1	Current NDC, Legacy NDC, 2 package rows	20221230_c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa.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 6 of 190 · 3,793 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	HyVee Inc	82ead335-d38e-40c3-8031-222bf985a302	2026-08-20	Warnings	Exact identifier application number: M012
HyVee Nighttime Severe Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	49818610-bf4a-fb86-e063-6294a90ae598	2026-08-20	Warnings	Exact identifier application number: M012
HyVee Daytime Severe Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	496ec389-1aea-f202-e063-6394a90ae51c	2026-08-20	Warnings	Exact identifier application number: M012
CVS PHARMACY COLD and COUGH And NIGHTTIME VALUE PACK	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	4d94968b-ada3-4344-8563-cba7fc491d74	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus chest congestion	GUAIFENESIN	CVS PHARMACY	bec04049-03b2-4465-9cf5-0ad2ef8014ef	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cough Relief	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY, INC	fe12f3bd-3237-42d1-aec5-c831b9637175	2026-08-19	Warnings	Exact identifier application number: M012
CVS Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CVS PHARMACY, INC	bfb3d021-f65f-499c-bbb1-c1aceb7a7bf9	2026-08-19	Warnings	Exact identifier application number: M012
CVS Long Acting Cough	DEXTROMETHORPHAN HBR	CVS PHARMACY, INC	31a7c0e2-af1c-45dd-8a93-e0879cae6005	2026-08-19	Warnings	Exact identifier application number: M012
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	b3baf939-a9fd-47ac-9bc7-68435e32ea1e	2026-08-19	Warnings	Exact identifier application number: M012
Multi Symptom Flu Relief Max Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	CVS PHARMACY	5151127a-4d09-413a-a08b-f76fb77e1188	2026-08-19	Warnings	Exact identifier application number: M012
CVS DT and NT Combo Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	360c8c62-0945-4031-b291-d40c4270b940	2026-08-19	Warnings	Exact identifier application number: M012
equate childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	24758ab0-ba08-4b4a-9861-449612bdb89c	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Mucus plus Chest Congestion	GUAIFENESIN	CVS PHARMACY	3cf425bd-9d90-4c19-a4f7-3cf7bd0b393a	2026-08-19	Warnings	Exact identifier application number: M012
CVS Childrens Cold plus Cough plus Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	CVS	7dc30e46-e289-40fc-b217-b123fee5daee	2026-08-19	Warnings	Exact identifier application number: M012
CVS ADULT COUGH PLUS CHEST CONGESTION DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	CVS PHARMACY	4490a7e1-d5b9-459c-8751-c24486807981	2026-08-19	Warnings	Exact identifier application number: M012
CVS DayTime and NightTime Value Pack Cold and Flu	ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE	CVS PHARMACY	4c813cd5-2c97-4fc3-926c-1a0396551a31	2026-08-19	Warnings	Exact identifier application number: M012
CVS Adult Cough plus Chest Congestion DM Max with Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS PHARMACY	822d5bf6-8841-4b7f-bbf7-90c3d50b8024	2026-08-19	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	2517b241-c433-440f-999d-5a32d5bbaa26	2026-08-19	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cough and Chest Congestion Childrens	DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE	CVS Pharmacy	347f1731-5b85-4220-ae2b-9497a3afa4ed	2026-08-19	Warnings	Exact identifier application number: M012
CVS Maximum Strength Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCL	CVS PHARMACY	e1c246a4-7a8c-4761-ab26-13b5165029cc	2026-08-19	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa	4
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa	4
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa	4
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	c4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69618-072-58	69618007258	1 BOTTLE in 1 CARTON (69618-072-58) / 237 mL in 1 BOTTLE	1 bottle	2022-12-01	0000-00-00	No	No	Current