FDA.reportPublic FDA data

GUAIFENESIN, DEXTROMETHORPHAN HBR

Product NDC
69729-783
11-digit product format
697290783
Labeler code
69729
Product ID
69729-783_5c3f7648-b025-9de5-e063-6394a90a7b6b
Type
HUMAN OTC DRUG
Nonproprietary name
GUAIFENESIN, DEXTROMETHORPHAN HBR
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
OPMX LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-18
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
400; 20 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
2027-12-31
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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69729-783-02834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69729-783-021332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69729-783-02fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69729-783-0286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69729-783-02bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
GUAIFENESIN, DEXTROMETHORPHAN HBR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-17TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2024-05-17TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2024-01-30TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2024-01-30TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2022-09-20TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2022-09-20TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2022-01-28TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)
2022-01-28TENALIF (DEXTROMETHORPHAN HBR 20MG, GUAIFENESIN 400MG SOFTGEL)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-783-02GUAIFENESIN, DEXTROMETHORPHAN HBR10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105
69729-783-02GUAIFENESIN, DEXTROMETHORPHAN HBR2 in 1 CARTONCAPSULE, LIQUID FILLED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-783GUAIFENESIN, DEXTROMETHORPHAN HBR CAPSULE, LIQUID FILLED [OPMX LLC]5Current NDC, Legacy NDC, 2 package rows20240518_9a246099-72b5-2efc-e053-2a95a90aafbc.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 91 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TARGET Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONbfc91c71-0506-4e94-8bfe-dc9e4bf959da2025-11-07WarningsExact identifier
application number: M012
CHILDRENS COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEH E B08f4785a-c628-4e9b-9412-b2a817f9be602025-11-07WarningsExact identifier
application number: M012
G-TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novisd169585f-b4f4-4831-8c71-e1533ae7e7c42025-11-07WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)1d512053-7a54-4691-a657-77da4c627cb82025-11-07WarningsExact identifier
application number: M012
Allergy and HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdc249163-26dd-42ca-b423-2f16299f2d652025-11-07WarningsExact identifier
application number: M012
Sinus CongestionPSEUDOEPHEDRINE HCLChain Drug Marketing Association, Inc.9744d04d-298d-4acd-9470-db9e7f2901e72025-11-07WarningsExact identifier
application number: M012
Daytime, Nighttime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc3b7fab1-f7fe-41be-a1c4-7ba4ba23c1592025-11-07WarningsExact identifier
application number: M012
Severe Cold and Flu Relief Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e2025-11-07WarningsExact identifier
application number: M012
Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLUACETAMINOPHEN, DEXTROMETHORPHAN HBRThe Procter & Gamble Manufacturing Companyff0bffee-9a36-8246-e053-6294a90a86c72025-11-06WarningsExact identifier
application number: M012
Xlear Nasal DecongestantNASAL SPRAYXlear Inc.1c1db71a-47d0-42ac-8cbe-95e76dca185f2025-11-06WarningsExact identifier
application number: M012
Robitussin Honey Cough DM Day Night Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLC1bbd0157-06e6-4a3b-bac9-91ac879ba0892025-11-06WarningsExact identifier
application number: M012
ValuMeds Nasal Decongestant Phenylephrine HClPHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.21676b0c-6be2-464c-ae91-92e5f0d0087d2025-11-06WarningsExact identifier
application number: M012
COLD AND FLU SEVERE Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.04715af5-e861-496c-834a-233eb73125562025-11-06WarningsExact identifier
application number: M012
Severe Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores Inc1a1f41c4-5430-4cff-873e-6547dadc87792025-11-06WarningsExact identifier
application number: M012
Target Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLTARGET CORPORATION05e944d5-3473-4d8c-8df4-2ffc7474e9fa2025-11-05WarningsExact identifier
application number: M012
Target Cough plus Chest Congestion DM Max with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINTARGET CORPORATIONe36f179e-5aed-4fee-8b0a-767bf35907522025-11-05WarningsExact identifier
application number: M012
Target Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORPORATION1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d22025-11-05WarningsExact identifier
application number: M012
Up and Up maximum Strength fast mucus relief Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationf007beaa-b108-46d5-8a98-853f011a8e2e2025-11-05WarningsExact identifier
application number: M012
Target Childrens Cough ReliefDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINTARGET CORPORATION975e157a-8f8d-41ad-b55b-9f9100188ccd2025-11-05WarningsExact identifier
application number: M012
Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCLTARGET CORPORATION6e94fdab-27ea-4c0f-a91c-735ce697304b2025-11-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661740dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral CapsulePSN9a246099-72b5-2efc-e053-2a95a90aafbc5
1661740dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral CapsuleSCD9a246099-72b5-2efc-e053-2a95a90aafbc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-783-02697290783022 BLISTER PACK in 1 CARTON (69729-783-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2019-02-180000-00-00NoNoCurrent