Altituss

Product NDC: 53163-113
11-digit product format: 531630113
Labeler code: 53163
Product ID: 53163-113_472ea5ae-3e91-42e3-e063-6294a90a4505
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: Alternative Pharmacal Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-03-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 15; 150 mg/7.5mL; mg/7.5mL
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: 2026-12-31
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	53163-113-16	`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	53163-113-16	`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: Altituss
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/7.5mL
GUAIFENESIN	150 mg/7.5mL

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
996520	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
e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53163-113-16	2020-12-23	C162847	48780-1	9d75b9cf-f956-f424-e053-dadaa90a57ce	Alt-Altituss 113
53163-113-16	2020-01-31	C162847	48780-1	9d75b9cf-f956-f424-e053-dadaa90a57ce	Alt-Altituss 113

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53163-113-16	Altituss	473 mL in 1 BOTTLE	LIQUID	473		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53163-113-16	ML - Milliliter	53163-113	5b9c9fd1-aced-4796-834e-5d4f8062a3cb	1	2025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)	INACTIVE INGREDIENT	R33S7TK2EP	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53163-113	ALTITUSS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	6	Current NDC, Legacy NDC, 1 package rows	20241228_e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44.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 86 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Robitussin Elderberry Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	fe903448-b422-42e0-b05b-aeb3e5481e3c	2025-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	1d4fcb76-22d1-7292-e063-6394a90af920	2025-11-25	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGH Soft CHEWS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	f22248b7-7abd-4df7-a986-dae357ebe8f1	2025-11-25	Warnings	Exact identifier application number: M012
ROBITUSSIN Nighttime Cough DM Soft CHEWS	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	39468746-e06d-4849-9d06-9af4d14351b0	2025-11-25	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Grocery Outlet, Inc.	4478fd51-bae3-6108-e063-6394a90a07ca	2025-11-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC.	395bb39a-e26f-f4f2-e063-6394a90ae721	2025-11-25	Warnings	Exact identifier application number: M012
day time	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	H E B	eaf3af6a-de5b-43fe-83ff-9641646e0f6b	2025-11-25	Warnings	Exact identifier application number: M012
MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	RB Health (US) LLC	38571853-992f-9998-e063-6394a90a8581	2025-11-24	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	e19b561c-fb76-4355-a306-d3dc46930bf2	2025-11-24	Warnings	Exact identifier application number: M012
Sinus Decongestion	PSEUDOEPHEDRINE HCL	Kroger Company	73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c	2025-11-24	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	Cardinal Health (Leader) 70000	14c507df-fbac-4a09-a66c-b91c2abbf550	2025-11-24	Warnings	Exact identifier application number: M012
Severe Nighttime Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI	Family Dollar (FAMILY WELLNESS)	e5c90d6e-70aa-4886-bc81-293e0dcf5638	2025-11-24	Warnings	Exact identifier application number: M012
Throat Coat Eucalyptus Mint	MENTHOL	Traditional Medicinals, Inc.	a7a86f1b-30e8-6f5d-e053-2a95a90a2a82	2025-11-21	Warnings	Exact identifier application number: M012
Throat Coat Sweet Orange Fennel	MENTHOL	Traditional Medicinals, Inc.	4538248f-11cc-d6b2-e063-6294a90a652c	2025-11-21	Warnings	Exact identifier application number: M012
up and up Daytime Nighttime Childrens Multi Symptom Cold	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Target Corporation	b8a4da0b-e4d3-48e6-b699-cb56c7b67ed7	2025-11-20	Warnings	Exact identifier application number: M012
Supress DX Pediatric Drops	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	KRAMER NOVIS	ddb95436-7806-4086-af4d-18a6625b5c83	2025-11-20	Warnings	Exact identifier application number: M012
Cough Drops Gems Flawless Cherry Flavor 30ct	MENTHOL	Riclan S.A.	0f0260df-89ac-4b83-afea-3aff56ff1b43	2025-11-18	Warnings	Exact identifier application number: M012
Cough Drops Gems Flawless Honey Lemon Flavor 30ct	MENTHOL	Riclan S.A.	16f6d531-9298-4172-8d08-ecd87d6add76	2025-11-18	Warnings	Exact identifier application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Haleon US Holdings LLC	a6f750c8-8738-4965-a3ad-612c24611056	2025-11-18	Warnings	Exact identifier application number: M012
YINCHIAO	ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE	ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.	09ba45f6-03e1-46b9-83ab-a618b2626716	2025-11-18	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
996520	dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution	PSN	e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44	7
996520	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44	7
996520	dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44	7
996520	dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution	SY	e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44	7
996520	dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution	SY	e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53163-113-16	53163011316	473 mL in 1 BOTTLE (53163-113-16)	473 ml	2015-03-01	0000-00-00	No	No	Current