good sense nighttime sleep aid
- Product NDC
- 0113-0431
- 11-digit product format
- 001130431
- Labeler code
- 0113
- Product ID
- 0113-0431_70250c98-1eb2-4522-bdc6-7ce5a1468fda
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L. Perrigo Company
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2001-04-25
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 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
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 | 0113-0431 | 0113-0431-68 | D | Discontinued by firm | 2026-10-15 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- good sense nighttime sleep aid
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049630 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0113-0431-62 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0a5b-111a-e063-dadaa90a10e2 | Perrigo Nighttime Sleep Aid Drug Facts |
| 0113-0431-68 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0a5b-111a-e063-dadaa90a10e2 | Perrigo Nighttime Sleep Aid Drug Facts |
| 0113-0431-78 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0a5b-111a-e063-dadaa90a10e2 | Perrigo Nighttime Sleep Aid Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0113-0431-62 | good sense nighttime sleep aid | 12 in 1 CARTON | TABLET, FILM COATED | 12 | 5 | |
| 0113-0431-62 | good sense nighttime sleep aid | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 5 | |
| 0113-0431-68 | good sense nighttime sleep aid | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 5 | |
| 0113-0431-68 | good sense nighttime sleep aid | 18 in 1 CARTON | TABLET, FILM COATED | 18 | 5 | |
| 0113-0431-78 | good sense nighttime sleep aid | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 5 | |
| 0113-0431-78 | good sense nighttime sleep aid | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-0431-62 | EA - Each | 0113-0431 | 9649502f-c6fa-4d7d-a6f7-a5202e5cda0e | 1 | 2012-07-24 |
| 0113-0431-78 | EA - Each | 0113-0431 | f5f22766-f73c-453c-bdb9-0283651b8829 | 1 | 2024-02-14 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 2d64f5c2-dfa9-e5f5-e063-6294a90a0711 | 2025-03-19 | Warnings | M010 |
| Sleep Aid Maximum Strength | DIPHENHYDRAMINE HCL | Harris Teeter, LLC | 322a71bb-fc68-4a03-8a24-20cbdbe6d91b | 2025-03-13 | Warnings | M010 |
| REVASOL SLEEP AID | DIPHENHYDRAMINE HCL | Rnv LLC | 30131010-be70-c940-e063-6394a90a190a | 2025-03-11 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 1a7189ba-2d52-44fc-83a4-b9f6156c62ff | 2025-03-07 | Warnings | M010 |
| meijer NIGHTTIME Sleep Aid SOFTGEL | DIPHENHYDRAMINE HYDROCHLORIDE | Meijer, Inc. | 1bede4cd-bf55-8b84-e063-6394a90aa5c9 | 2025-02-19 | Warnings | M010 |
| PHARBEDRYL | DIPHENHYDRAMINE HCL 50MG | Ulai Health LLC | 135293fb-5674-4638-be55-b968cf51257e | 2025-01-20 | Warnings | M010 |
| Allergy Relief 25 mg | DIPHENHYDRAMINE HCL 25MG | Ulai Health LLC | 751f13d4-c4d6-47a5-b40d-1563de08c048 | 2025-01-12 | Warnings | M010 |
| RoboCough | DEXTROMETHORPHAN HBR | DXM Pharmacuetical, Inc. | 32fa7a09-8624-44c1-b9e4-8a8f0594292b | 2025-01-10 | Warnings | M010 |
| SleepAid (Diphenhydramine HCL) | DIPHENHYDRAMINE HCL | APNAR PHARMA LP | faaf5d51-d81d-3acc-e053-6294a90ae08f | 2025-01-09 | Warnings | M010 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 971515fa-b4d2-1197-e053-2995a90a838d | 2025-01-03 | Warnings | M010 |
| Nighttime Sleep-Aid Softgel | DIPHENHYDRAMINE HYDROCHLORIDE | CVS PHARMACY, INC | 8b0fa259-6702-4667-bac6-f7d0b0839ae0 | 2025-01-01 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | 9f1c078d-e537-4ec0-8ae9-54c98282be29 | 2024-12-31 | Warnings | M010 |
| Discount Drugmart Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | Discount Drug Mart, Inc | d6d77c2e-42b3-48f0-a662-3872155ef34d | 2024-12-18 | Warnings | M010 |
| Kroger Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | THE KROGER CO | 98437a72-1b98-4301-b92f-0c17b305cf59 | 2024-12-18 | Warnings | M010 |
| equate nighttime sleep aid | DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | 6e162152-b414-470c-b146-649d99870577 | 2024-12-17 | Warnings | M010 |
| Quality Choice Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Chain Drug Marketing Association, Inc. | e8b2858b-a737-c500-e053-2995a90adba6 | 2024-12-16 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | f99cc210-b946-42a2-9164-8aa5308c5418 | 2024-12-11 | Warnings | M010 |
| CalmCo Sleep Aid Gummy Bite | DIPHENHYDRAMINE HCL | CalmCo LLC | 0c534cbd-40e6-8af0-e063-6394a90a5605 | 2024-12-07 | Warnings | M010 |
| Somnapure Clinical Strength | DIPHENHYDRAMINE HYDROCHLORIDE | Force Factor Brands LLC | 063517c0-bcb1-46dd-85f1-bbb2f24274ef | 2024-12-06 | Warnings | M010 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | AAA Pharmaceutical, Inc. | c280cf02-ebb2-4847-a66d-d02aff3ea0c9 | 2024-12-02 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 5 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0113-0431-62 | 00113043162 | 12 BLISTER PACK in 1 CARTON (0113-0431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK | 12 blister pack | 2001-04-25 | 0000-00-00 | No | No | Current |
| 0113-0431-68 | 00113043168 | 18 BLISTER PACK in 1 CARTON (0113-0431-68) > 2 TABLET, FILM COATED in 1 BLISTER PACK | 18 blister pack | 2019-05-21 | 0000-00-00 | No | No | Current |
| 0113-0431-78 | 00113043178 | 1 BOTTLE in 1 CARTON (0113-0431-78) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-12-29 | 0000-00-00 | No | No | Current |