FDA.reportPublic FDA data

Berro y Cebolla

Product NDC
53145-080
11-digit product format
531450080
Labeler code
53145
Product ID
53145-080_3a8a5464-a24f-ca2c-e063-6294a90aa0fe
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Menper Distributors, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 100 mg/15mL; mg/15mL
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

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
Berro y Cebolla
Brand name suffix
DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
GUAIFENESIN100 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1298228Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
20107bd9-6d84-4ab5-a0d9-966f1f11d919Available 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-080-082023-07-28C16284748780-1d6a99b39-d42d-a426-e053-dadaa90af4c2Berro y Cebolla
53145-080-082022-02-18C16284748780-1d6a99b39-d42d-a426-e053-dadaa90af4c2Berro y Cebolla
53145-080-082022-01-28C16284748780-1d6a99b39-d42d-a426-e053-dadaa90af4c2Berro y Cebolla

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-080-08Berro y CebollaDM237 mL in 1 BOTTLELIQUID2375
53145-080-08Berro y CebollaDM1 in 1 CARTONLIQUID15

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 58 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mixed Berry Throat and Cough LozengesBENZOCAINECVS Pharmacy737b1c88-1a44-68cf-e053-2991aa0a35b62026-01-16WarningsExact identifier
application number: M012
Walgreens Wild Cherry Throat DropsPECTINWalgreens4885eca3-c1e9-8350-e063-6394a90ac2902026-01-16WarningsExact identifier
application number: M012
HBP Chest Congestion and Cough ReliefGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEWalgreensff7a1462-9994-4421-85aa-c03488bb04cf2026-01-16WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRWALGREEN COMPANYa793acbc-107c-4638-a2d7-65f4e96cafda2026-01-16WarningsExact identifier
application number: M012
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEWalgreensca53ec26-d167-1780-e053-2a95a90a5b882026-01-16WarningsExact identifier
application number: M012
Maximum Strength Congestion and HeadacheACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens88da92d2-92c2-445a-9b70-58996e0860142026-01-16WarningsExact identifier
application number: M012
Maximum Strength Cold and FluACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens5f638bca-55c2-4ead-8c47-3f15713495da2026-01-16WarningsExact identifier
application number: M012
COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens190175bb-c08a-4050-aacf-29a130cbe05c2026-01-16WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEFSA Store Inc. (Caring Mills)a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff2026-01-16WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLL.N.K. International, Inc.99147338-f459-4423-ae54-f96fffc1728d2026-01-15WarningsExact identifier
application number: M012
SanaTos Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC144aafcc-6ec2-a322-e063-6294a90afc272026-01-15WarningsExact identifier
application number: M012
SanaTos Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC14484bf5-ff45-b859-e063-6394a90a9a0f2026-01-15WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion Relief PE PEGUAIFENESIN/PHENYLEPHRINEStrategic Sourcing Services LLC3429aedc-e83d-498a-bfca-03aaf5847b3b2026-01-15WarningsExact identifier
application number: M012
Quality Choice Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association4b86101c-00f8-4ede-807f-db4273b37b8d2026-01-15WarningsExact identifier
application number: M012
Quality Choice Mucus Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINChain Drug Marketing Associationd1ba7267-6844-4a14-b518-65277a32e8552026-01-15WarningsExact identifier
application number: M012
ACTINEL DM PediatricDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLCf85d8586-423f-48a3-9bb2-bbc5984c7cd32026-01-15WarningsExact identifier
application number: M012
ACTINEL DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINACTIPHARMA, LLC35c21623-84dd-4151-b35b-e7d30b69c9c02026-01-15WarningsExact identifier
application number: M012
Pocket FarmacyMENTHOLSaje Natural Business Inc.bdc15c6f-73b4-488e-9134-e70565df71bb2026-01-14WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCL 50 MGDIPHENHYDRAMINE HCLYYBA Corporation4b012549-3958-43c1-9de7-897c5d8b20d32026-01-14WarningsExact identifier
application number: M012
Rite Aid Pharmacy congestion relief vaporizing steamVAPORIZING STEAMRite Aid Pharmacy0fb86b23-0313-8fd8-e063-6394a90a0f5f2026-01-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298228dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 15 mL Oral SolutionPSN20107bd9-6d84-4ab5-a0d9-966f1f11d9195
1298228dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 6.67 MG/ML Oral SolutionSCD20107bd9-6d84-4ab5-a0d9-966f1f11d9195
1298228dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 15 ML Oral SolutionSY20107bd9-6d84-4ab5-a0d9-966f1f11d9195
1298228dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 30 ML Oral SolutionSY20107bd9-6d84-4ab5-a0d9-966f1f11d9195

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53145-080-08531450080081 BOTTLE in 1 CARTON (53145-080-08) / 237 mL in 1 BOTTLE1 bottle2019-04-010000-00-00NoNoCurrent