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…`

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 1 of 195 · 3,890 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime Nighttime Intense Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	03aa43fd-4962-4c2c-9edd-e422a629a0e3	2026-08-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f311b56f-b959-4070-9b23-82c642dd98b8	2026-08-06	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	2ed25f69-89ef-4c50-946a-7e7b9df1ca8a	2026-08-06	Warnings	Exact identifier application number: M012
Eucamint	MENTHOL, CAMPHOR	Indiana Botanic Gardens	d79bc8de-9efb-4996-a55c-accda0f8edb2	2026-08-06	Warnings	Exact identifier application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc	b745f45d-2042-4daa-9932-241836d7734b	2026-08-06	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	NUVICARE LLC	6713fdff-0e4e-4a9d-b218-34f786339c57	2026-08-06	Warnings	Exact identifier application number: M012
Daytime Cold, Nighttime Cold multi-symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	3b462a5d-d48b-4b73-b5d4-d7944730bbdd	2026-08-06	Warnings	Exact identifier application number: M012
Sinufrin Quick Relief Decongestant	SINUFRIN	Neilmed pharmaceuticals Inc.	0c36a34e-462d-713c-e063-6294a90a1776	2026-08-05	Warnings	Exact identifier application number: M012
No Drip	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	e9b799ad-9164-7f30-e053-2a95a90a00c5	2026-08-05	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreen Company	78edeb7a-4712-4f04-9d76-d5b2d20ce76d	2026-08-04	Warnings	Exact identifier application number: M012
CareOne Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	c9342ad2-84dc-4f4c-9b05-c6e5c1c7989e	2026-08-04	Warnings	Exact identifier application number: M012
dg health cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp Inc	3d8ce88e-9f40-4b58-a811-160ddbfb8112	2026-08-04	Warnings	Exact identifier application number: M012
ValuRx Dye Free Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Shield Pharmaceuticals Corp	ca60a413-b02e-48ce-985d-4d415780c679	2026-08-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	150b68ba-3ed4-4533-9118-74e76eaf6e48	2026-08-04	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	ce393bff-498b-42e6-a41c-bbfbc58fb42c	2026-08-04	Warnings	Exact identifier application number: M012
Sinus and Headache	ACETAMINOPHEN AND PHENYLEPHRINE HCL	Cardinal Health 110, LLC. DBA Leader	3b8662bf-3abb-4e54-af9c-5fa1d2e19003	2026-08-04	Warnings	Exact identifier application number: M012
Mucus Relief PE	GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	cb1c1922-5dc6-520d-e77e-e951726d9701	2026-08-04	Warnings	Exact identifier application number: M012
Chest Congestion Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	DOLGENCORP, LLC	da053bc3-e790-4ae9-a406-2629640e97e7	2026-08-04	Warnings	Exact identifier application number: M012
Cold and Flu plus Congestion Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WALMART INC.	1236b463-0073-44b5-a516-5b7c06a40887	2026-08-04	Warnings	Exact identifier application number: M012
daytime nitetime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	80aae1c3-a616-442b-842e-177db957a69c	2026-08-04	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