FDA.reportPublic FDA data

Guaifenesin and Dextromethorphan HBR

Product NDC
51316-009
11-digit product format
513160009
Labeler code
51316
Product ID
51316-009_2885f0f5-e5ad-b667-c442-753a48d3f900
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan HBR
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA217340
Marketing category
ANDA
Marketing start
2023-08-15
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
30; 600 mg/1; mg/1
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01
A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEDEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217340-001GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE30MG;600MGTABLET, EXTENDED RELEASE / ORAL2023-08-01a50c72e98297…
2026-08-01 22:54:322026-06A217340-002GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE60MG;1.2GMTABLET, EXTENDED RELEASE / ORAL2023-08-01a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Members Mark Mucus Relief DMGUAIFENESIN AND DEXTROMETHORPHAN HBRSAM'S WEST INC2b59f90b-b8fc-03c0-3527-a8efa97fbfe32025-11-30WarningsExact identifier
application applno (ANDA): 217340
application number: ANDA217340
Guaifenesin and Dextromethorphan HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRDr. Reddy's Laboratories Inc.5e95d8c0-d521-45b6-ccaf-7786fbd14d5c2025-11-30WarningsExact identifier
application applno (ANDA): 217340
application number: ANDA217340
Guaifenesin and Dextromethorphan HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRCVS Pharmacy7942eeae-0528-4416-bd2f-b05acc71c0a92024-11-10WarningsExact identifier
application applno (ANDA): 217340
application number: ANDA217340
ndc (product): 51316-009
Guaifenesin and Dextromethorphan HBRGUAIFENESIN AND DEXTROMETHORPHAN HBRDr. Reddy's Laboratories Inc.49d7f70d-ff79-0708-3eda-efa5bf61da6c2024-03-19WarningsExact identifier
application applno (ANDA): 217340
application number: ANDA217340

Additional Listing Data#

Finished product
Yes
Brand name base
Guaifenesin and Dextromethorphan HBR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN30 mg/1
DEXTROMETHORPHAN HYDROBROMIDE600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1298324Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7942eeae-0528-4416-bd2f-b05acc71c0a9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-009-01Guaifenesin and Dextromethorphan HBR20 in 1 BLISTER PACKTABLET, EXTENDED RELEASE204
51316-009-01Guaifenesin and Dextromethorphan HBR5 in 1 CARTONTABLET, EXTENDED RELEASE54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-009GUAIFENESIN AND DEXTROMETHORPHAN HBR TABLET, EXTENDED RELEASE [CVS PHARMACY]4Current NDC, 2 package rows20241112_7942eeae-0528-4416-bd2f-b05acc71c0a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298324guaiFENesin 600 MG / dextromethorphan HBr 30 MG 12HR Extended Release Oral TabletPSN7942eeae-0528-4416-bd2f-b05acc71c0a94
129832412 HR dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG Extended Release Oral TabletSCD7942eeae-0528-4416-bd2f-b05acc71c0a94
1298324dextromethorphan hydrobromide 30 MG / guaifenesin 600 MG 12 HR Extended Release Oral TabletSY7942eeae-0528-4416-bd2f-b05acc71c0a94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-009-01513160009015 BLISTER PACK in 1 CARTON (51316-009-01) / 20 TABLET, EXTENDED RELEASE in 1 BLISTER PACK5 blister pack2023-08-15NoNoCurrent