NDC 70518-1265-3 - Hydroxyzine hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 70518-1265
- Requested NDC
- 70518-1265-3
- Package NDCs from labels
- 70518-1265-0, 70518-1265-1, 70518-1265-3, 70518-1265-2, 70518-1265-5, 70518-1265-4
- Manufacturer
- REMEDYREPACK INC.
- Effective date
- 2026-09-29
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Rx only | REMEDYREPACK INC. | 2026-09-29 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-1265-0 | Hydroxyzine hydrochloride | 30 in 1 BLISTER PACK | TABLET | 30 | 14 | |
| 70518-1265-1 | Hydroxyzine hydrochloride | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | 14 | |
| 70518-1265-2 | Hydroxyzine hydrochloride | 100 in 1 BOX | TABLET | 100 | 14 | |
| 70518-1265-3 | Hydroxyzine hydrochloride | 1 in 1 POUCH | TABLET | 1 | 14 | |
| 70518-1265-4 | Hydroxyzine hydrochloride | 100 in 1 BOX | TABLET | 100 | 14 | |
| 70518-1265-5 | Hydroxyzine hydrochloride | 1 in 1 POUCH | TABLET | 1 | 14 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-1265 | HYDROXYZINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.] | 10 | Current NDC, Legacy NDC, 6 package rows | 20250510_4c2c4d8e-c3d1-48c7-8f99-ffa159667465.zip |
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 |
|---|---|---|---|---|---|---|
| HydrOXYzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | 5dea636d-dee6-47d4-b83c-b9f0c0b1b6ca | 2026-07-24 | Warnings, Adverse reactions | 995218 76755771U3 |
| ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | BEL STAR S.A. | 575fb2c3-e332-8a3b-e063-6394a90a9fd9 | 2026-07-24 | Warnings | 15FIX9V2JP |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | St. Mary's Medical Park Pharmacy | 30b6f7b3-b620-961a-e063-6394a90a487b | 2026-07-23 | Warnings, Adverse reactions | 995258 76755771U3 |
| True Coast SPF 50 Mineral Sunscreen | ZINC OXIDE 18%, TITANIUM DIOXIDE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 5379466d-8d14-5fc2-e063-6394a90abd7e | 2026-07-22 | Warnings | 15FIX9V2JP |
| Droptics Dry Eye Relief | CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80 | Droptics LLC | 29d7614b-f4b7-48e2-97c5-d1bff27731d2 | 2026-07-22 | Warnings | 6OZP39ZG8H |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | SICOS ET CIE | 571f23e9-1126-e32d-e063-6294a90a9951 | 2026-07-21 | Warnings | 15FIX9V2JP |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | APOZEAL PHARMACEUTICALS INC | 87d4bbff-0498-4c26-86cb-7ce173afa0b6 | 2026-07-21 | Warnings, Adverse reactions | 76755771U3 |
| HydrOXYzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | A-S Medication Solutions | be6a2f09-c0f3-44e2-aac3-37e3702b93f0 | 2026-07-21 | Warnings, Adverse reactions | 995281 76755771U3 |
| Hydroxyzine Hydrochloride | HYDROXYZINE HYDROCHLORIDE | Cardinal Health 107, LLC | b4d274ce-d616-4835-80ce-76270524ed36 | 2026-07-20 | Warnings, Adverse reactions | 995258 76755771U3 |
| MENS SPF50 ALL IN ONE SUNSCREEN | MENS SPF50 ALL IN ONE SUNSCREEN | Lance (Guangzhou) Biological Technology Co., Ltd. | 57074480-77fd-cc06-e063-6294a90a28d4 | 2026-07-20 | Warnings | 15FIX9V2JP |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | L'Oreal USA Products Inc | 5711364c-f9b4-bfa6-e063-6294a90ace4a | 2026-07-20 | Warnings | 15FIX9V2JP |
| Prid | ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR | Hyland's Inc. | 49689eeb-7790-07f1-e063-6294a90a2df2 | 2026-07-16 | Warnings | ETJ7Z6XBU4 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Major Pharmaceuticals | 7f76580c-96a0-4b56-8986-ff5488bb9869 | 2026-07-15 | Warnings, Adverse reactions | ANDA204279 995218 995281 995258 76755771U3 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | bb4a7d22-2f42-4e9f-bf98-cee43ed14d50 | 2026-07-15 | Warnings, Adverse reactions | ANDA204279 995281 76755771U3 |
| Leg Cramps PM | OYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFUR | Hyland's Inc. | b0574a7e-88fa-417e-b6d5-60ced59eba47 | 2026-07-15 | Warnings | ETJ7Z6XBU4 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc | c8b441bf-a03e-47b3-8f06-c347f5ca4b70 | 2026-07-15 | Warnings, Adverse reactions | ANDA204279 995218 76755771U3 |
| Hydroxyzine hydrochloride | HYDROXYZINE HYDROCHLORIDE | REMEDYREPACK INC. | b6189074-e199-4f58-a78d-c04f131c13d9 | 2026-07-10 | Warnings, Adverse reactions | ANDA204279 995258 76755771U3 |
| Jacksons Cell Salts SILICA 12X 12 | SILICEA | Zettl Health Inc. | 5647dafc-1fff-6a25-e063-6294a90a8b4f | 2026-07-10 | ETJ7Z6XBU4 | |
| HYDROXYZINE HYDROCHLORIDE | HYDROXYZINE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 5648abce-f20e-717c-e063-6294a90a88ac | 2026-07-10 | Warnings, Adverse reactions | 995258 76755771U3 |
| Bombee Honey Daily Glow Shield Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE | ABT ASIA Inc. | 56112dff-b091-7a56-e063-6294a90a77d3 | 2026-07-08 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.