Home NDC 29978-587-01 Aquanaz
Product NDC 29978-587
Requested package NDC 29978-587-01
11-digit product format 299780587
Labeler code 29978
Product ID 29978-587_4485648d-222a-31b7-e063-6394a90a84e8
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Guaifenesin and Phenylephrine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Capital Pharmaceutical, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2015-03-10
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 15; 400; 10 mg/1; mg/1; mg/1
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 · 1 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 2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 29978-587 29978-587-01 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Additional Listing Data#
Finished product Yes
Brand name base Aquanaz
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 GUAIFENESIN 400 mg/1 PHENYLEPHRINE HYDROCHLORIDE 10 mg/1
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 1552200 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 29978-587-01 Aquanaz 100 in 1 BOTTLE TABLET 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29978-587 AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20241201_5e9e4dfd-4def-4756-9bba-d25068640101.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 29978-587-01 29978058701 100 TABLET in 1 BOTTLE (29978-587-01) 100 tablet 2015-03-10 0000-00-00 No No Current