FDA.reportPublic FDA data

Aquanaz

Product NDC
29978-587
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
GUAIFENESIN400 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
Rxcui1552200

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
29978-587-012025-12-02C16284748780-19d75b9d0-48a0-f424-e053-dadaa90a57ceAquanaz Tablets
29978-587-012025-07-29C16284748780-19d75b9d0-48a0-f424-e053-dadaa90a57ceAquanaz Tablets
29978-587-012024-02-14C16284748780-19d75b9d0-48a0-f424-e053-dadaa90a57ceAquanaz Tablets
29978-587-012024-01-30C16284748780-19d75b9d0-48a0-f424-e053-dadaa90a57ceAquanaz Tablets
29978-587-012020-03-12C16284748780-19d75b9d0-48a0-f424-e053-dadaa90a57ceAquanaz Tablets
29978-587-012020-01-31C16284748780-19d75b9d0-48a0-f424-e053-dadaa90a57ceAquanaz Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29978-587-01Aquanaz100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29978-587-01EA - Each29978-5872ec15a1f-c3d8-4efb-b15b-0ef21fa783de12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHAQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1
GUAIFENESINACTIVE INGREDIENT495W7451VQAQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJAQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSAQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1
GUAIFENESINACTIVE MOIETY495W7451VQAQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVAQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29978-587AQUANAZ (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [CAPITAL PHARMACEUTICAL, LLC]6Current NDC, Legacy NDC, 1 package rows20241201_5e9e4dfd-4def-4756-9bba-d25068640101.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1552200dextromethorphan HBr 15 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral TabletPSN5e9e4dfd-4def-4756-9bba-d250686401017
1552200dextromethorphan hydrobromide 15 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD5e9e4dfd-4def-4756-9bba-d250686401017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
29978-587-0129978058701100 TABLET in 1 BOTTLE (29978-587-01) 100 tablet2015-03-100000-00-00NoNoCurrent