Dr Simi Mucus Relief Expectorant

Product NDC
85786-301
11-digit product format
857860301
Labeler code
85786
Product ID
85786-301_3c6d0e75-a686-6020-e063-6294a90a5c1b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Farmacias De Similares TX LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-15
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Dr Simi Mucus Relief Expectorant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310621Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c6d0e75-a685-6020-e063-6294a90a5c1bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85786-301-14Dr Simi Mucus Relief Expectorant14 in 1 BOTTLETABLET, EXTENDED RELEASE141

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 61 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berkley and Jensen Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINBJWCc15b97a8-968f-4d38-905e-863e9fd16ce62026-01-06WarningsExact identifier
application number: M012
Complete Allergy MedicineDIPHENHYDRAMINE HCLSalado Sales, Inc.c0f5c8ca-b187-40bf-9245-6a29f1c32c972026-01-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leaderc5776b1e-9f72-4a6a-9961-8ac8e05b32492026-01-06WarningsExact identifier
application number: M012
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incb9215a5e-3be8-44fd-9189-50dab760869c2026-01-06WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMajor Pharmaceuticalsf81efbf4-204b-45be-ae32-910d9e4ae4aa2026-01-06WarningsExact identifier
application number: M012
SINUS AND NASAL DECONGESTANTPSEUDOEPHEDRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd7646859-f996-46cd-a0b9-56b860f609012026-01-05WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLHY-VEE, INC47a71cdf-856d-9ecd-e063-6294a90a70c62026-01-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINOncor Pharmaceuticalsfd35036c-b722-48a3-85fd-60471beb6e742026-01-05WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLNuCare Pharmaceuticals,Inc.3c323dc8-f734-b44c-e063-6394a90a61842026-01-05WarningsExact identifier
application number: M012
Congestion and Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYf43d97b1-aeb9-4ca5-8909-b28e7bf764f52026-01-05WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLC6bd2b8fd-2023-413b-8988-a47d2058dc852026-01-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWinCo Foods, LLC4c1046df-53a6-4219-83ac-bbf5cf4db9c82026-01-05WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC80323208-9ba5-432b-a8a0-0c0b51e671452026-01-05WarningsExact identifier
application number: M012
Sinus Pressure and Pain PE Maximum StrengthACETAMINOPHEN AND PHENYLEPHRINE HCLRite Aid Corporation347868e4-0182-4e16-895c-ec269895c57c2026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.c5b11a9c-6d93-4772-93c2-1ef5c56470162026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops Honey LemonMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fae96736-1453-42fe-8158-cde770b231652026-01-02WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.8cac1229-8e8e-4d8c-9f18-c2cd0f6f50bd2026-01-02WarningsExact identifier
application number: M012
Reliable-1 TussinGUAIFENESINRELIABLE 1 LABORATORIES LLC2a33ff82-49df-7aaa-e063-6294a90a12812026-01-02WarningsExact identifier
application number: M012
Tussin DMMaxDEXTROMETHORPHAN HBR, GUAIFENESINRELIABLE 1 LABORATORIES LLCc4bb2e12-e0f6-4cbf-ad24-cfad9326f7fa2026-01-02WarningsExact identifier
application number: M012
Severe Sinus Pain and Congestion DaytimeACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy4af347ce-9745-4a5e-8ce9-e7c97a0a6cc72026-01-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN3c6d0e75-a685-6020-e063-6294a90a5c1b1
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD3c6d0e75-a685-6020-e063-6294a90a5c1b1
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY3c6d0e75-a685-6020-e063-6294a90a5c1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85786-301-148578603011414 TABLET, EXTENDED RELEASE in 1 BOTTLE (85786-301-14) 2025-08-15NoNoCurrent