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 |
|---|---|---|---|---|---|---|
| Sleep Aid | DIPHENHYDRAMINE HCL | Rite Aid Corporation | fbedb50d-b96f-4ce4-a1dc-d2b357cf6de1 | 2026-05-13 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | Family Dollar Services Inc | 8ebd9949-ef53-4d66-a20c-3e0047b3e1ef | 2026-05-13 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | CVS Pharmacy | 0be4ef9a-2484-41dd-8bb8-e92d411f1384 | 2026-05-11 | Warnings | M010 |
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | AMERISOURCE BERGEN | ca052b38-de38-7bf0-e053-2995a90a4e85 | 2026-05-11 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Strategic Sourcing Services LLC | e68d96c8-21c5-406c-b22c-3e384027c79f | 2026-05-07 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Kroger Company | b71bb567-5605-430b-b3fa-048fe9bbe8ff | 2026-05-04 | Warnings | M010 |
| Sleep II Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Walgreen Company | ed864c84-a430-4ca8-87e8-04f1c1df538b | 2026-05-04 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Walgreen Company | f8f17615-e4ec-49d4-9c0d-581d0fd6feb7 | 2026-04-28 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | L.N.K. International, Inc. | 888dc258-d5a3-4b62-aea1-c81ea29ff6f5 | 2026-04-28 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Amerisource Bergen | 8f1cb631-4633-4ef5-868e-48a46ab311a4 | 2026-04-27 | Warnings | M010 |
| Nightime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | BETTER LIVING BRANDS LLC. | 202bb1ff-3273-4872-e063-6294a90abebb | 2026-04-11 | Warnings | M010 |
| Vicks ZzzQuil Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | The Procter & Gamble Manufacturing Company | 1be2f00b-5bdd-82e7-e063-6394a90ab9a5 | 2026-04-06 | Warnings | M010 |
| Night Time Sleep Aid | DIPHENHYDRAMINE HCL | HyVee Inc | cf94fa56-01a5-4d6c-ad08-38b0ea363399 | 2026-04-03 | Warnings | M010 |
| Sleep-Aid | DIPHENHYDRAMINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 84ec323d-0523-41e8-856c-e02d6afdc9ec | 2026-04-02 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | 6c9b7576-428a-4884-8331-bb312c9046bd | 2026-04-01 | Warnings | M010 |
| Calmco Sleep Aid | DIPHENHYDRAMINE HCL | CalmCo LLC | 471d4c70-813a-19de-e063-6394a90aeb25 | 2026-03-31 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | The Kroger Co. | 0db543bb-c6c3-4370-a70c-e1652781fd7d | 2026-03-25 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL 50MG | Grocery Outlet | 57a751e9-d8b6-4527-8537-bc4be718f5ec | 2026-03-17 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Walgreen Company | df7a43d1-83a7-4e86-baef-4b9d1ebf0dbb | 2026-03-16 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Grocery Outlet, Inc. | 4454df6a-931f-3f03-e063-6294a90afe73 | 2026-03-14 | 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 |