Zyrtec Allergy, Lil Drug Store
- Product NDC
- 66715-9811
- 11-digit product format
- 667159811
- Labeler code
- 66715
- Product ID
- 66715-9811_1b6c945f-5920-8869-e063-6294a90ad397
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Cetirizine Hydrochloride tablet, film coated
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Lil' Drug Store Products, Inc.
- Application
- NDA019835
- Marketing category
- NDA
- Marketing start
- 2024-07-10
- Substance
- CETIRIZINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019835-003 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | RLD | 2007-11-16 | |
| N019835-004 | ZYRTEC ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | |
| N019835-005 | ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | RLD | 2007-11-16 | |
| N019835-006 | ZYRTEC HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | RLD | 2007-11-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-005 | ZYRTEC HIVES | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019835-006 | ZYRTEC HIVES | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-005 | ZYRTEC HIVES RELIEF | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019835-006 | ZYRTEC HIVES RELIEF | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-005 | ZYRTEC HIVES RELIEF | 5MG | TABLET / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019835-006 | ZYRTEC HIVES RELIEF | 10MG | TABLET / ORAL | RLD | 2007-11-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019835-003 | ZYRTEC ALLERGY | 5MG | TABLET / ORAL | RLD | 2007-11-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019835-004 | ZYRTEC ALLERGY | 10MG | TABLET / ORAL | RLD, RS | 2007-11-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019835-005 | ZYRTEC HIVES RELIEF | 5MG | TABLET / ORAL | RLD | 2007-11-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019835-006 | ZYRTEC HIVES RELIEF | 10MG | TABLET / ORAL | RLD | 2007-11-16 | d8e5a09893c0… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zyrtec Allergy, Lil Drug Store
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CETIRIZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 64O047KTOA | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1b6c945f-591f-8869-e063-6294a90ad397 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be | Product name | 1 | 20200304 |
| a255659f-db40-429d-8c07-5f173f330d9c | Product name | 1 | 20190402 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66715-9811-1 | Zyrtec Allergy, Lil Drug Store | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 1 | |
| 66715-9811-1 | Zyrtec Allergy, Lil Drug Store | 1 in 1 POUCH | TABLET, FILM COATED | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66715-9811 | ZYRTEC ALLERGY, LIL DRUG STORE (CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.] | 1 | Current NDC, 2 package rows | 20240712_1b6c945f-591f-8869-e063-6294a90ad397.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 |
|---|---|---|---|---|---|---|
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Select Consumer Group | 568960cf-2c8f-f1b0-e063-6294a90aebc7 | 2026-07-13 | Warnings | 019835 NDA019835 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Savings Distributors LLC | 5490c38a-91d7-9ee1-e063-6394a90a1ea5 | 2026-06-01 | Warnings | 019835 NDA019835 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | b165db38-b302-4220-8627-77cb07bb078c | 2025-10-10 | Warnings | 019835 NDA019835 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 6685a843-9dbe-4f9e-b75b-fe0e258f4155 | 2025-10-08 | Warnings | 019835 NDA019835 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 2c1ecee3-c2c1-25a2-e063-6294a90aad54 | 2025-07-21 | Warnings | 019835 NDA019835 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Morning Star OTC | 3efa421d-ea70-4b1f-95d0-7c63b6c39580 | 2025-06-19 | Warnings | 019835 NDA019835 |
| ZYRTEC Hives | CETIRIZINE HYDROCHLORIDE | Kenvue Brands LLC | 31136e3a-94fa-0860-e063-6394a90a008d | 2025-06-16 | Warnings | 019835 NDA019835 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | RedPharm Drug Inc | f4c1f9fd-2d32-71d3-e053-2a95a90a3ba4 | 2025-01-23 | Warnings | 019835 NDA019835 |
| Zyrtec 1s Blister | CETIRIZINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | 3a595eb8-2409-4598-8704-ab59b57bd062 | 2024-12-31 | Warnings | 019835 NDA019835 |
| Zyrtec 2s Blister | CETIRIZINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | af0ba7b0-b511-9f81-e053-2a95a90ade2c | 2024-12-31 | Warnings | 019835 NDA019835 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc | a4146629-57f0-42e0-b905-df364a8a99f5 | 2024-12-31 | Warnings | 019835 NDA019835 |
| Zyrtec Allergy, Lil Drug Store | CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 1b6c945f-591f-8869-e063-6294a90ad397 | 2024-06-21 | Warnings | 019835 NDA019835 66715-9811 |
| Zyrtec Allergy | CETIRIZINE HYDROCHLORIDE | Navajo Manufacturing Company Incorporated | 9c4693cb-f066-0666-e053-2a95a90a96d3 | 2023-03-16 | Warnings | 019835 NDA019835 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1014678 | cetirizine HCl 10 MG Oral Tablet | PSN | 1b6c945f-591f-8869-e063-6294a90ad397 | 1 |
| 1020026 | ZyrTEC 10 MG Oral Tablet | PSN | 1b6c945f-591f-8869-e063-6294a90ad397 | 1 |
| 1020026 | cetirizine hydrochloride 10 MG Oral Tablet [Zyrtec] | SBD | 1b6c945f-591f-8869-e063-6294a90ad397 | 1 |
| 1014678 | cetirizine hydrochloride 10 MG Oral Tablet | SCD | 1b6c945f-591f-8869-e063-6294a90ad397 | 1 |
| 1014678 | cetirizine HCl 10 MG Oral Tablet | SY | 1b6c945f-591f-8869-e063-6294a90ad397 | 1 |
| 1020026 | Zyrtec (cetirizine dihydrochloride 10 MG) Oral Tablet | SY | 1b6c945f-591f-8869-e063-6294a90ad397 | 1 |
| 1020026 | Zyrtec 10 MG Oral Tablet | SY | 1b6c945f-591f-8869-e063-6294a90ad397 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 66715-9811-1 | 66715981101 | 1 POUCH in 1 CARTON (66715-9811-1) / 1 TABLET, FILM COATED in 1 POUCH | 1 pouch | 2024-07-10 | No | No | Current |