Indications and uses
For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.
MECLIZINE HYDROCHLORIDE
- Manufacturer
- Physicians Total Care, Inc.
- Effective date
- 2010-09-15
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:11:36
Label at a glance#
ProductMECLIZINE HYDROCHLORIDE
Active ingredientMeclizine Hydrochloride
Label structure10 sections
Dosage and administration
Motion Sickness: The initial dose of 25 to 50 mg meclizine hydrochloride, should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
Label contents#
Full prescribing information#
DESCRIPTION
Meclizine hydrochloride, an oral antiemetic, is a white, slightly yellowish, crystalline powder which has a slight odor and is tasteless. It has the following structural formula:
| C25H27CIN2•2HCI•H2O | M.W. 481.89 |
The chemical name is 1-(p-chloro-alpha-phenylbenzyl)-4-(m-methyl-benzyl) - piperazine dihydrochloride monohydrate.
Meclizine Hydrochloride Tablets are available in 12.5 mg, and *25 mg strengths for oral administration.
*Contains FD&C Yellow #5 (see PRECAUTIONS).
Each tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch, stearic acid and other ingredients. In addition, the 12.5 mg tablet contains FD&C Blue #1; and the 25 mg tablet contains D&C Yellow #10 and FD&C Yellow #5.
CLINICAL PHARMACOLOGY
Meclizine hydrochloride is an antihistamine which shows marked protective activity against nebulized histamine and lethal doses of intravenously injected histamine in guinea pigs. It has a marked effect in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. Its activity is relatively weak in inhibiting the spasmogenic action of histamine on isolated guinea pig ileum.
INDICATIONS AND USAGE
For the prevention and treatment of nausea, vomiting, or dizziness associated with motion sickness.
CONTRAINDICATIONS
Meclizine hydrochloride is contraindicated in individuals who have shown a previous hypersensitivity to it.
WARNINGS
Since drowsiness may, on occasion, occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery.
Patients should avoid alcoholic beverages while taking the drug. Due to its potential anticholinergic action, this drug should be used with caution in patients with asthma, glaucoma, or enlargement of the prostate gland. Do not give to children under 12 years of age unless directed by a doctor.
PRECAUTIONS
The Meclizine Hydrochloride Tablets, 25 mg contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow #5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Usage in Children: Clinical studies establishing safety and effectiveness in children have not been done; therefore, usage is not recommended under 12 years of age.
Usage in Pregnancy:Pregnancy Category B. Reproduction studies in rats have shown cleft palates at 25-50 times the human dose. Epidemiological studies in pregnant women, however, do not indicate that meclizine hydrochloride increases the risk of abnormalities when administered during pregnancy.
Despite the animal findings, it would appear that the possibility of fetal harm is remote. Nevertheless, meclizine hydrochloride, or any other medication should be used during pregnancy only if clearly necessary.
ADVERSE REACTIONS
Drowsiness, dry mouth, and on rare occasions, blurred vision have been reported.
DOSAGE AND ADMINISTRATION
Motion Sickness: The initial dose of 25 to 50 mg meclizine hydrochloride, should be taken one hour prior to travel for protection against motion sickness. Thereafter, the dose may be repeated every 24 hours for the duration of the journey.
HOW SUPPLIED
Meclizine Hydrochloride Tablets, USP 12.5 mg - blue, oval tablets debossed with “034” on one side and “par” on the other side. Tablets may contain characteristic dye spots. They are supplied in
| Bottles of 15 | NDC 54868-0089-0 |
| Bottles of 30 | NDC 54868-0089-2 |
| Bottles of 50 | NDC 54868-0089-7 |
| Bottles of 100 | NDC 54868-0089-4 |
Meclizine Hydrochloride Tablets, USP 25 mg - yellow, oval tablets debossed with “035” on one side and “par” on the other side. They are supplied in
| Bottles of 15 | NDC 54868-0077-1 |
| Bottles of 20 | NDC 54868-0077-7 |
| Bottles of 30 | NDC 54868-0077-4 |
| Bottles of 40 | NDC 54868-0077-3 |
| Bottles of 60 | NDC 54868-0077-8 |
| Bottles of 90 | NDC 54868-0077-2 |
| Bottles of 100 | NDC 54868-0077-5 |
Dispense in tight, light-resistant containers as defined in the USP.
Store at controlled room temperature 15°-30°C (59°-86°F).
Manufactured by:
PAR PHARMACEUTICAL COMPANIES, INC.
Spring Valley, NY 10977
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
PRINCIPAL DISPLAY PANEL
Meclizine Hydrochloride Tablets, USP
12.5 mg
Meclizine Hydrochloride Tablets, USP
25 mg
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| MECLIZINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac6963c4-31c6-325f-ee58-83a0a06597ad | Product name | 5 | 20221206 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-0077-1 | MECLIZINE HYDROCHLORIDE | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | 1 | |
| 54868-0077-2 | MECLIZINE HYDROCHLORIDE | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | 1 | |
| 54868-0077-3 | MECLIZINE HYDROCHLORIDE | 40 in 1 BOTTLE, PLASTIC | TABLET | 40 | 1 | |
| 54868-0077-4 | MECLIZINE HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 | |
| 54868-0077-5 | MECLIZINE HYDROCHLORIDE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 1 | |
| 54868-0077-7 | MECLIZINE HYDROCHLORIDE | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | 1 | |
| 54868-0077-8 | MECLIZINE HYDROCHLORIDE | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 1 | |
| 54868-0089-0 | MECLIZINE HYDROCHLORIDE | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | 1 | |
| 54868-0089-2 | MECLIZINE HYDROCHLORIDE | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 | |
| 54868-0089-4 | MECLIZINE HYDROCHLORIDE | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | 1 | |
| 54868-0089-7 | MECLIZINE HYDROCHLORIDE | 50 in 1 BOTTLE, PLASTIC | TABLET | 50 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-0077 | MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | 7 package rows | 20110404_c65aee98-bddf-4cf7-8d78-17253704b1ab.zip |
| 54868-0089 | MECLIZINE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | 4 package rows | 20110404_c65aee98-bddf-4cf7-8d78-17253704b1ab.zip |
DailyMed Billing Units#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Meclizine Hydrochloride | ACTIVE INGREDIENT | HDP7W44CIO | 1 | |
| Meclizine | ACTIVE MOIETY | 3L5TQ84570 | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 1 | |
| Magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Products#
Every source-derived product name is available through these pages.
- MECLIZINE HYDROCHLORIDE
- Meclizine
- SILICON DIOXIDE
- LACTOSE
- Magnesium stearate
- CELLULOSE, MICROCRYSTALLINE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STARCH, CORN
- Stearic Acid
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 5
- D&C YELLOW NO. 10
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54868-0089 | 54868-0089-0, 54868-0089-2, 54868-0089-4, 54868-0089-7 |
| 49884-034 | |
| 54868-0077 | 54868-0077-1, 54868-0077-2, 54868-0077-3, 54868-0077-4, 54868-0077-5, 54868-0077-7, 54868-0077-8 |
| 49884-035 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / TOPICAL | 0.06 %w/w | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GUM, CHEWING / ORAL | 2 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / SUBLINGUAL | 43.2 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SYRUP / ORAL | 0.05 mg/5ml | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 53 mg | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 133 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, COATED / ORAL | 0.52 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE / DENTAL | NA | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, COATED / ORAL | 184 mg | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 9 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / BUCCAL | 0.11 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SOLUTION / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SUSPENSION / ORAL | 76 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET / SUBLINGUAL | 17.5 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | DOUCHE / VAGINAL | NA | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, DELAYED RELEASE / ORAL | 144 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | LIQUID / ORAL | NA | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / VAGINAL | 4 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, EXTENDED RELEASE / ORAL | 2.03 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 615 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUPPOSITORY / RECTAL | 0.11 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | CONCENTRATE / BUCCAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, EXTENDED RELEASE / ORAL | 14 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | TABLET / BUCCAL | 296.7 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, EXTENDED RELEASE / ORAL | 5119 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / ORAL | 180 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | SUPPOSITORY / VAGINAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, FILM COATED / ORAL | 1.68 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | EMULSION / TOPICAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SUSPENSION, EXTENDED RELEASE / ORAL | 1 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / SUBLINGUAL | 0.11 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | INJECTION / INTRAVENOUS | 203.5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | SUSPENSION / ORAL | 64 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE / ORAL | 26.3 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, DELAYED RELEASE / ORAL | 2210 mg | ||
| LACTOSE | LACTOSE | J2B2A4N98G | CONCENTRATE / ORAL | NA | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | GRANULE, FOR SUSPENSION / ORAL | 278 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / ORAL | 6184 mg | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | GRANULE / ORAL | 629 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| Magnesium stearate | MAGNESIUM STEARATE | 70097M6I30 | TABLET, FOR SUSPENSION / ORAL | 131 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A087127-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 74a2ff9319b5… | |
| 2020-11-12 02:37 UTC | 2020-11 | A087127-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A087127-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A087127-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A087127-001 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | ea99ee380514… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A087127-001 | AA | 1 | 74a2ff9319b5… |
| 2020-11-12 02:37 UTC | 2020-11 | A087127-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A087127-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A087127-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A087127-001 | AA | 1 | ea99ee380514… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087128-001 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | |
| A087128-002 | MECLIZINE HYDROCHLORIDE | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A087128-001 | AA |
| A087128-002 | AA |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | c2088c7a36db… | |
| 2026-10-15 13:18:30 | 2026-09 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A087128-001 | MECLIZINE HYDROCHLORIDE | 25MG | TABLET / ORAL | AA | Approved before 1982 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A087128-002 | MECLIZINE HYDROCHLORIDE | 12.5MG | TABLET / ORAL | AA | Approved before 1982 | 4b0b4de00fa7… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A087128-001 | AA | 1 | c2088c7a36db… |
| 2026-10-15 13:18:30 | 2026-09 | A087128-002 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A087128-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A087128-002 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A087128-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A087128-002 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A087128-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A087128-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087128-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087128-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A087128-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A087128-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087128-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087128-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087128-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087128-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087128-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087128-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087128-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087128-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087128-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087128-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087128-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087128-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A087128-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A087128-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087128-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087128-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087128-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087128-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087128-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087128-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A087128-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A087128-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087128-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087128-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A087128-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A087128-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A087128-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A087128-002 | AA | 1 | 4b0b4de00fa7… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3bbc3f5c-6e8f-40ac-b134-63c722ea4afc | c65aee98-bddf-4cf7-8d78-17253704b1ab | 2010-09-15 | Warnings, Adverse reactions | 3bbc3f5c-6e8f-40ac-b134-63c722ea4afc c65aee98-bddf-4cf7-8d78-17253704b1ab |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.