Altipres

Product NDC: 53163-104
Requested package NDC: 53163-104-16
11-digit product format: 531630104
Labeler code: 53163
Product ID: 53163-104_472ecc1a-795d-b592-e063-6394a90a1bb2
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: Alternative Pharmacal Corporation
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2013-05-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 10; 200; 5 mg/5mL; mg/5mL; mg/5mL
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: 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53163-104	53163-104-16	I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53163-104	53163-104-16	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

Additional Listing Data#

Finished product: Yes
Brand name base: Altipres
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/5mL
GUAIFENESIN	200 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE	5 mg/5mL

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
1098647	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
c5a43107-3eb8-46bb-87bd-20deafe28c3f	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
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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
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
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53163-104-16	2020-12-23	C162847	48780-1	9d75b9d0-1120-f424-e053-dadaa90a57ce	Alt-Altipres 104
53163-104-16	2020-01-31	C162847	48780-1	9d75b9d0-1120-f424-e053-dadaa90a57ce	Alt-Altipres 104

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53163-104-16	Altipres	473 mL in 1 BOTTLE	LIQUID	473		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53163-104-16	ML - Milliliter	53163-104	6a9ca9ed-9029-49fd-8498-8cefec315e73	1	2025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)	INACTIVE INGREDIENT	S38J6RZN16	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53163-104	ALTIPRES (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [ALTERNATIVE PHARMACAL CORPORATION]	5	Current NDC, Legacy NDC, 1 package rows	20241228_c5a43107-3eb8-46bb-87bd-20deafe28c3f.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 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d1115a55-35cd-4f20-8872-f42983a5ebcd	2026-07-28	Warnings	Exact identifier application number: M012
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	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
1098647	dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution	PSN	c5a43107-3eb8-46bb-87bd-20deafe28c3f	6
1098647	dextromethorphan hydrobromide 2 MG/ML / guaifenesin 40 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution	SCD	c5a43107-3eb8-46bb-87bd-20deafe28c3f	6
1098647	dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution	SY	c5a43107-3eb8-46bb-87bd-20deafe28c3f	6
1098647	dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution	SY	c5a43107-3eb8-46bb-87bd-20deafe28c3f	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53163-104-16	53163010416	473 mL in 1 BOTTLE (53163-104-16)	473 ml	2013-05-01	0000-00-00	No	No	Current