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 161 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Maximum Strength Cold Tabs	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	JHK DBA American Safety & First Aid	e7d4fe9a-eb09-4266-90c9-290f61ce6ad0	2024-07-15	Warnings	Exact identifier application number: M012
ACTIDOM DA	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	7797c22e-ffeb-4798-9fb6-aa64cf077ba7	2024-07-15	Warnings	Exact identifier application number: M012
Nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	1cf3064d-4ddd-63b9-e063-6294a90aa547	2024-07-11	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	TARGET CORPORATION	1ccbdb53-3f70-28da-e063-6394a90a9ae0	2024-07-09	Warnings	Exact identifier application number: M012
AXIV Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1cd2a6f1-31ad-e507-e063-6394a90aba58	2024-07-09	Warnings	Exact identifier application number: M012
Poly Hist Forte	DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	8aa0015b-8fc1-7951-e053-2a95a90a8e72	2024-07-09	Warnings	Exact identifier application number: M012
DECONEX DMX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	8aab8e5c-1633-2e5a-e053-2a95a90adcc5	2024-07-09	Warnings	Exact identifier application number: M012
Deconex IR	GUAIFENESIN AND PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	4710095e-3dae-4a39-8a98-873012e1f003	2024-07-09	Warnings	Exact identifier application number: M012
Diabetic Tussin Sore Throat and Cough Cherry	BENZOCAINE AND DEXTROMETHORPHAN HBR	MEDTECH PRODUCTS INC	e9327079-e0fc-4c95-b1d5-bc1b74870c9b	2024-07-09	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	fac859a4-e23a-4879-af6c-26368455506d	2024-07-05	Warnings	Exact identifier application number: M012
Severe Throat Drops	MENTHOL ICE	Target Corporation Inc.	1876b221-fa60-5269-e063-6394a90a6963	2024-07-04	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf911bf-eafe-fe46-e063-6294a90a3903	2024-07-03	Warnings	Exact identifier application number: M012
Family Wellness Effervescent Cold Relief Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Family Dollar Services, Inc.	4e13511b-fbb5-2523-e054-00144ff88e88	2024-07-03	Warnings	Exact identifier application number: M012
Nighttime Cherry Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	TARGET CORPORATION	1c3f6cbf-a00d-45b9-e063-6394a90a797c	2024-07-02	Warnings	Exact identifier application number: M012
Cold Terminator Cold Relief	PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Wildman Business Group	e8538d9c-f9ba-40b1-b60f-f57921f39b64	2024-07-01	Warnings	Exact identifier application number: M012
Nighttime Severe Honey Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	1c02e465-8750-a088-e063-6394a90a8efb	2024-06-29	Warnings	Exact identifier application number: M012
ACTIDOM DMX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	0166322e-7dbb-4658-a5c5-1d0525bb7655	2024-06-28	Warnings	Exact identifier application number: M012
ACTINEL DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	ACTIPHARMA, LLC	16660d82-524b-42ca-8581-48237caa13b2	2024-06-28	Warnings	Exact identifier application number: M012
PurgenLabs Acetaminophen	ACTAMINOPHEN	Advanced Rx LLC	915c4608-af1b-4119-8291-4ce9fd701d76	2024-06-28	Warnings	Exact identifier application number: M012
Daytime Ultra Concentrated Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	1bc90b2f-612c-e977-e063-6294a90a40b4	2024-06-26	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