Cetirizine Hydrochloride Tablets

Manufacturer
Wal-Mart Stores Inc
Effective date
2014-05-09
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 01:36:21

Label at a glance#

ProductAllergy Relief
Active ingredientCETIRIZINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat   .

Dosage and administration

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

Storage and handling

store between 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Cetirizine HCl, 10mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat 

.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

When using this product

OTC - WHEN USING SECTION

  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

OTC - STOP USE SECTION

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If breast-feeding: not recommended
  • if pregnant: 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

adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide.

Questions?

OTC - QUESTIONS SECTION

call 1-888-375-3784.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

10 mg Container Labelingcontainercartoncontainercarton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-131-60EA - Each55111-1310f78e0cf-e93c-462a-ac98-19f5df90981412018-12-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOA6
CETIRIZINEACTIVE MOIETYYO7261ME246
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I306
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ6
POVIDONEINACTIVE INGREDIENTFZ989GH94E6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP6

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-01049035-010-74
55111-131

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii+route+dosage form
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
POVIDONEPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii+route+dosage form

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 · 2 matching rows.

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075294-001RANITIDINE HYDROCHLORIDERANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075294-001RANITIDINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2000-03-28f41ea6bd6efb…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078343-001CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2008-01-15
A078343-002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2008-01-15
A078343-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2008-01-15
A078343-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2008-01-15

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1584e616aacf4f…
2026-09-14 22:38:342026-08A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1584e616aacf4f…
2026-08-18 06:07:402026-07A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-155bbf6a4d5a75…

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
RanitidineRANITIDINEDr. Reddy's Laboratories Limited12a38e29-130c-6d41-1753-acccb0b41efe2025-05-23WarningsExact identifier
ndc (product): 55111-131
7c72e74f-c713-feb3-d4cc-d90e1320d76cb2270eaf-d62b-392c-ee48-bc8563c3efc52019-12-18WarningsExact identifier
spl set id: b2270eaf-d62b-392c-ee48-bc8563c3efc5

Reported adverse events (FAERS/openFDA)#

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