FDA.reportPublic FDA data

Mucinex

Manufacturer
Bryant Ranch Prepack
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
monthly-update
Hydrated at
2026-07-17 21:36:56

Label at a glance#

ProductMucinex
Active ingredientGUAIFENESIN
Label structure12 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and administration

do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each extended-release bi-layer tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 600 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • for children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF

Questions?

OTC - QUESTIONS SECTION

1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Dist. by: RB Health (US)
Parsippany, NJ 07054-0224

Made in England

HOW SUPPLIED

How Supplied Section

Guaifenesin Extended-Release Bi-Layer Tablets 600 mg

  • NDC 63629-7115-1: 30 Tablets in a Bottle
  • NDC 63629-7115-2: 20 Tablets in a Bottle
  • NDC 63629-7115-3: 60 Tablets in a Bottle
  • NDC 63629-7115-4: 40 Tablets in a Bottle
  • NDC 63629-7115-5: 14 Tablets in a Bottle

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Guaifenesin Extended-Release Bi-Layer Tablets 600 mg

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeData Matrix(01)00363629711512(21)0123456789(17)280629(10)208820GTIN-14: 00363629711512
GTIN-12: 363629711512
UPC-A: 363629711512
EAN-13: 0363629711512
GTIN storage (14 digits): 00363629711512		lbl636297115.jpg
QR code linkQR Codedailymed.nlm.nih.gov/dailymed/search.cfm?adv=1&query=NDC:63629-7115-1lbl636297115.jpg
Data codeCode 1286362971151lbl636297115.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-7115-12024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52024-05-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52024-01-30C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52020-10-16C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-12020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-22020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-32020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-42020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®
63629-7115-52020-01-31C16284748780-19d75b9d0-0ba1-f424-e053-dadaa90a57ceMucinex ®

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-008-10EA - Each63824-0088a8fe46e-a8dd-4e88-a43a-b5cb234a182912012-07-24
63824-008-15EA - Each63824-008825a9c5e-a011-46d2-99d6-82b24621a35c12012-07-24
63824-008-24EA - Each63824-00872c29d28-4125-47bc-a9ec-025f76ffd69612021-04-08
63824-008-27EA - Each63824-008a3f2c15b-af9a-4992-9bc6-7c96ac06d52812012-07-24
63824-008-32EA - Each63824-008c12fa728-b6ba-4d9e-bf3c-e1fc7a5bc37c12012-07-24
63824-008-34EA - Each63824-0085a5a0482-291d-411b-bb0d-c85d2367ceaf12012-07-24
63824-008-36EA - Each63824-00825620952-bffc-449b-b2e6-ae1d2775da2912015-08-04
63824-008-50EA - Each63824-008e12bb389-684d-4137-99d0-3e29d2382e4012012-07-24
63824-008-61EA - Each63824-008ce5a1472-3ac2-498b-9b40-7c3466571b8212012-07-24
63824-008-62EA - Each63824-0083b8a427e-50ac-43b6-8ba5-13928b4404c312012-07-24
63824-008-69EA - Each63824-008d3a2bb0a-6b5f-41cd-9303-be145966acbe12012-07-24
63824-008-80EA - Each63824-00804e1bccb-c1ee-4f6c-aa00-e5c02d9d507312021-04-08
63824-008-86EA - Each63824-0087dec4237-179d-4a1b-a329-3781acde223812016-09-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63629-711563629-7115-1, 63629-7115-2, 63629-7115-3, 63629-7115-4, 63629-7115-5, 63629-7115-6, 63629-7115-7
63824-008

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112024-04-02full-release2026-06-01 00:12:43

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021282-001MUCINEXGUAIFENESIN600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12
N021282-002MUCINEXGUAIFENESIN1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1284e616aacf4f…
2026-09-14 22:38:342026-08N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1884e616aacf4f…
2026-08-18 06:07:402026-07N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021282-001MUCINEX600MGTABLET, EXTENDED RELEASE / ORALRLD2002-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-002MUCINEX1.2GMTABLET, EXTENDED RELEASE / ORALRLD, RS2002-12-1874a2ff9319b5…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021282-00163722522020-04-28U-48974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00169558212020-04-28U-489Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00178380322020-04-28Drug product2010-12-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00263722522020-04-28U-48974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00269558212020-04-28U-489Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021282-00278380322020-04-28Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021282-00163722522020-04-28U-4898869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00169558212020-04-28U-489Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00178380322020-04-28Drug product2010-12-218869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00263722522020-04-28U-4898869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00269558212020-04-28U-489Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021282-00278380322020-04-28Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021282-00163722522020-04-28U-489c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00169558212020-04-28U-489Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00178380322020-04-28Drug product2010-12-21c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00263722522020-04-28U-489c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00269558212020-04-28U-489Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021282-00278380322020-04-28Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021282-00163722522020-04-28U-4893f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00169558212020-04-28U-489Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00178380322020-04-28Drug product2010-12-213f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00263722522020-04-28U-4893f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00269558212020-04-28U-489Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021282-00278380322020-04-28Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021282-00163722522020-04-28U-489b00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00169558212020-04-28U-489Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00178380322020-04-28Drug product2010-12-21b00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00263722522020-04-28U-489b00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00269558212020-04-28U-489Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021282-00278380322020-04-28Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021282-00163722522020-04-28U-489ea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00169558212020-04-28U-489Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00178380322020-04-28Drug product2010-12-21ea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00263722522020-04-28U-489ea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00269558212020-04-28U-489Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021282-00278380322020-04-28Drug productea99ee380514…

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MucinexGUAIFENESINBryant Ranch Prepacka898b584-e17e-45c4-8a28-9f686b95dca02026-06-29WarningsExact identifier
ndc (package): 63629-7115-6
ndc (package): 63629-7115-2
ndc (package): 63629-7115-3
ndc (package): 63629-7115-1
ndc (package): 63629-7115-4
ndc (package): 63629-7115-5
ndc (package): 63629-7115-7
ndc (product): 63629-7115
ndc11 (package): 63629711503
ndc11 (package): 63629711507
ndc11 (package): 63629711505
ndc11 (package): 63629711502
ndc11 (package): 63629711506
ndc11 (package): 63629711504
ndc11 (package): 63629711501
spl id: 14931cd1-5c04-4801-aa6e-18138a21b28e
spl set id: a898b584-e17e-45c4-8a28-9f686b95dca0
MucinexGUAIFENESINReckitt Benckiser LLCdd379cdd-90ab-42e0-ad89-f50d3220f6112026-05-27WarningsExact identifier
ndc (product): 63824-008

Reported adverse events (FAERS/openFDA)#

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