Sleep Aid
- Product NDC
- 0363-8020
- 11-digit product format
- 003638020
- Labeler code
- 0363
- Product ID
- 0363-8020_bbd1d1a4-9d44-42ca-ac3c-a7cb6cbbcfbb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine HCl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-03-10
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 50 mg/30mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0363-8020 | 0363-8020-96 | D | Discontinued by firm | 2026-10-16 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sleep Aid
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 50 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1248354 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f8f17615-e4ec-49d4-9c0d-581d0fd6feb7 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-8020-02 | Sleep Aid | 355 mL in 1 BOTTLE, PLASTIC | SOLUTION | 355 | 7 | |
| 0363-8020-45 | Sleep Aid | 177 mL in 1 BOTTLE, PLASTIC | SOLUTION | 177 | 7 | |
| 0363-8020-96 | Sleep Aid | 355 mL in 1 BOTTLE, PLASTIC | SOLUTION | 355 | 7 | |
| 0363-8020-96 | Sleep Aid | 2 in 1 PACKAGE | SOLUTION | 2 | 7 | |
| 0363-8020-97 | Sleep Aid | 2 in 1 CARTON | SOLUTION | 2 | 7 | |
| 0363-8020-97 | Sleep Aid | 355 mL in 1 BOTTLE, PLASTIC | SOLUTION | 355 | 7 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy, Inc. | 6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f | 2024-12-02 | Warnings | M010 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | CVS Pharmacy, Inc. | 6dd802ec-fc26-3913-e053-2a91aa0ad05d | 2024-12-02 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | PUBLIX SUPER MARKETS INC | 236ff457-0ec1-9c49-e063-6394a90a707a | 2024-11-26 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 50d74111-6d1b-4681-a264-f7e550320259 | 2024-11-25 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | efb05387-72c0-4643-8541-b7990c202ce6 | 2024-11-25 | Warnings | M010 |
| Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6oz | DIPHENHYDRAMINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 2781fc28-8a7d-d0fa-e063-6394a90ac793 | 2024-11-22 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 7830ce18-908a-4f86-a238-8c31cfe47ce6 | 2024-11-21 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | f8de6605-4a0a-492d-beb5-f414ce8bfb0e | 2024-11-20 | Warnings | M010 |
| Nighttime SLEEP AID | DIPHENHYDRAMINE HCL 50MG | PuraCap Pharmaceutical LLC | 272a7138-2a97-8e62-e063-6394a90a1af1 | 2024-11-18 | Warnings | M010 |
| ZzzQuil | DIPHENHYDRAMINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 0b2777be-85d4-443d-b65f-6750e0ba97ba | 2024-11-18 | Warnings | M010 |
| RiteAid Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN | RITE AID CORPORATION | 54fc0893-9702-4849-a702-3e84dc9ead03 | 2024-10-30 | Warnings | M010 |
| Rite Aid Nighttime Sleep Aid Non Habit Forming | DIPHENHYDRAMINE HYDROCHLORIDE | RITE AID CORPORATION | 59ba6824-fa6c-4b3f-9f1f-ea194766c8a1 | 2024-10-30 | Warnings | M010 |
| GOOD REMEDIES Nighttime Sleep Aid Caplets | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 24fba735-cedf-9d15-e063-6394a90af873 | 2024-10-29 | Warnings | M010 |
| Premier Value Nighttime Sleep-Aid Liquid Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Consortium | 6d24b6e1-7959-47c6-a09b-c7e00a437495 | 2024-10-28 | Warnings | M010 |
| Nytol | DIPHENHYDRAMINE HCL | Medtech Products Inc. | c81d018a-0170-4396-81e9-2e13a53f868a | 2024-10-25 | Warnings | M010 |
| Rest Simply | DIPHENHYDRAMINE HYDROCHLORIDE | Marc Glassman, Inc. | 2ab3852d-53a4-411b-a9ad-3ef88ab3ee87 | 2024-10-23 | Warnings | M010 |
| nitetime sleep aid | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 43184abd-2525-402a-a388-85af2e5c13ad | 2024-10-17 | Warnings | M010 |
| Good Sense Sleep Time | DIPHENHYDRAMINE HCL | L. Perrigo Company | 164200a9-b1f8-44c9-8598-a7dff5020e9d | 2024-10-16 | Warnings | M010 |
| Equaline Night Time Sleep Aid | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 6d34ee3e-3d61-481e-98d6-acfa066e4247 | 2024-10-16 | Warnings | M010 |
| basic care nighttime sleep aid | DIPHENHYDRAMINE HCL | Amazon.com Services LLC | 027de5ea-5c07-4960-8a98-8cf2c0e54a92 | 2024-10-16 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1248354 | diphenhydrAMINE HCl 50 MG in 30 mL Oral Solution | PSN | f8f17615-e4ec-49d4-9c0d-581d0fd6feb7 | 7 |
| 1248354 | diphenhydramine hydrochloride 1.67 MG/ML Oral Solution | SCD | f8f17615-e4ec-49d4-9c0d-581d0fd6feb7 | 7 |
| 1248354 | diphenhydramine HCl 1.667 MG/ML Oral Solution | SY | f8f17615-e4ec-49d4-9c0d-581d0fd6feb7 | 7 |
| 1248354 | diphenhydramine HCl 50 MG per 30 ML Oral Solution | SY | f8f17615-e4ec-49d4-9c0d-581d0fd6feb7 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-8020-02 | 00363802002 | 355 mL in 1 BOTTLE, PLASTIC (0363-8020-02) | 355 ml | 2022-03-10 | 0000-00-00 | No | No | Current |
| 0363-8020-45 | 00363802045 | 177 mL in 1 BOTTLE, PLASTIC (0363-8020-45) | 177 ml | 2022-03-10 | 0000-00-00 | No | No | Current |
| 0363-8020-96 | 00363802096 | 2 BOTTLE, PLASTIC in 1 PACKAGE (0363-8020-96) > 355 mL in 1 BOTTLE, PLASTIC | 2022-03-10 | 0000-00-00 | No | No | Current | |
| 0363-8020-97 | 00363802097 | 2 BOTTLE, PLASTIC in 1 CARTON (0363-8020-97) / 355 mL in 1 BOTTLE, PLASTIC | 2022-03-10 | No | No | Current |